ACIS 08.843.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705034761626), received between Dec 12, 2017 and Jun 22, 2021 — classified as 26 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TOTAL OF (B)(4)PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID 11: A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID 19: A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS - THAT RES

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 12045648 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6) A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -

  Patient problems: Pain

  MAUDE report 12045566 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TOTAL OF 50 PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS ID 70: A 71-YEAR-OLD PATIENT (BMI = 38.36). DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS. POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS ID 11: A 78-YEAR-OLD PATIENT (BMI = 25.25). SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS ID 19: A 64-YEAR-OLD PATIENT (BMI = 28.5). DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS - THAT RESOLVED BEF

  Patient problems: Dysphagia/ Odynophagia; Fatigue; Pain

  MAUDE report 12045559 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 12045545 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -

  Patient problems: Numbness; Pain

  MAUDE report 12045474 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA) FROM CARILION CLINIC. A TOTAL OF 50 PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS PER IDENTIFIER HAVE BEEN IDENTIFIED AS FOLLOWS IN THE INITIAL REPORT: ID 2: A 42-YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. ID 3: A 45-YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYI

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 12044290 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TOTAL OF 50 PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS. - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36). DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS. POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS. - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25). SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS. - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5). DYSPHAGIA: PROCEDURE RELATED: 17 PATIENT

  Patient problems: Pain

  MAUDE report 12041792 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) AND DUA DATA LISTING FOR THE ACIS RETROSPECTIVE STUDY COMPLETED AS PART OF THE PMCF PLAN. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS HAVE BEEN IDENTIFIED AS PER CARILLON CLINIC EMR - RETROSPECTIVE REVIEW: A (B)(6) FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. A (B)(6) PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYING DOWN; COMPLAINTS OF SOME ISSUES WITH SWALLOWING. A (B)(6) PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. A (B)(6) PATIENT (BMI = 34.2) EXPERIENCED DIFFICULTY SWALLOWING SINCE SURGERY HAS IMPROVED; NECK PAIN AND NUMBNESS/ TINGLING DOWN ARMS; HAD COMPLAINTS OF SOME TINGLING IN THE LEFT ARM THAT IS MOD AND INTERMITTENT NECK PAIN; CHRONIC

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 12041778 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) AND DUA DATA LISTING FOR THE ACIS RETROSPECTIVE STUDY COMPLETED AS PART OF THE PMCF PLAN. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS HAVE BEEN IDENTIFIED AS PER CARILLON CLINIC EMR - RETROSPECTIVE REVIEW: ID (B)(6): A (B)(6) YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. ID (B)(6): A (B)(6) YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYING DOWN; COMPLAINTS OF SOME ISSUES WITH SWALLOWING. ID (B)(6): A (B)(6) YEAR-OLD PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. ID (B)(6): A (B)(6) YEAR-OLD PATIENT (BMI = 34.2) EXPERIENCED DIFFICULTY SWALLOWING SINCE SURGERY HAS IMPROVED; NECK PAIN AND NUMBNESS/ TINGLING DOWN ARMS; HAD COMPLAINTS OF S

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 12037719 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 12037536 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) AND DUA DATA LISTING FOR THE ACIS RETROSPECTIVE STUDY COMPLETED AS PART OF THE PMCF PLAN. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS HAVE BEEN IDENTIFIED AS PER CARILLON CLINIC EMR - RETROSPECTIVE REVIEW: ID (B)(6): A (B)(6)-YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. ID (B)(6): A (B)(6)-YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYING DOWN; COMPLAINTS OF SOME ISSUES WITH SWALLOWING. ID (B)(6): A (B)(6)-YEAR-OLD PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. ID (B)(6): A (B)(6)-YEAR-OLD PATIENT (BMI = 34.2) EXPERIENCED DIFFICULTY SWALLOWING SINCE SURGERY HAS IMPROVED; NECK PAIN AND NUMBNESS/ TINGLING DOWN ARMS; HAD COMPLAINTS OF S

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 12037504 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -

  Patient problems: Hematoma; Pain

  MAUDE report 12037487 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) AND DUA DATA LISTING FOR THE ACIS RETROSPECTIVE STUDY COMPLETED AS PART OF THE PMCF PLAN. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS HAVE BEEN IDENTIFIED AS PER CARILLON CLINIC EMR - RETROSPECTIVE REVIEW: ID (B)(6): A (B)(6) YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. ID (B)(6): A (B)(6) YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYING DOWN; COMPLAINTS OF SOME ISSUES WITH SWALLOWING. ID (B)(6): A (B)(6) YEAR-OLD PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. ID (B)(6): A (B)(6) YEAR-OLD PATIENT (BMI = 34.2) EXPERIENCED DIFFICULTY SWALLOWING SINCE SURGERY HAS IMPROVED; NECK PAIN AND NUMBNESS/ TINGLING DOWN ARMS; HAD COMPLAINTS OF S

  Patient problems: Dysphagia/ Odynophagia; Numbness

  MAUDE report 12037415 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -

  Patient problems: Hematoma

  MAUDE report 12037001 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) AND DUA DATA LISTING FOR THE ACIS RETROSPECTIVE STUDY COMPLETED AS PART OF THE PMCF PLAN. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS HAVE BEEN IDENTIFIED AS PER CARILLON CLINIC EMR - RETROSPECTIVE REVIEW: ID (B)(6): A (B)(6)-YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. ID (B)(6): A (B)(6)-YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYING DOWN; COMPLAINTS OF SOME ISSUES WITH SWALLOWING. ID (B)(6): A (B)(6)-YEAR-OLD PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. ID (B)(6): A (B)(6)-YEAR-OLD PATIENT (BMI = 34.2) EXPERIENCED DIFFICULTY SWALLOWING SINCE SURGERY HAS IMPROVED; NECK PAIN AND NUMBNESS/ TINGLING DOWN ARMS; HAD COMPLAINTS OF S

  Patient problems: Muscular Rigidity

  MAUDE report 12036998 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 12036992 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) AND DUA DATA LISTING FOR THE ACIS RETROSPECTIVE STUDY COMPLETED AS PART OF THE PMCF PLAN. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS HAVE BEEN IDENTIFIED AS PER CARILLON CLINIC EMR - RETROSPECTIVE REVIEW: ID (B)(6): A (B)(6) YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. ID (B)(6) : A (B)(6) YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYING DOWN; COMPLAINTS OF SOME ISSUES WITH SWALLOWING. ID (B)(6) : A (B)(6) YEAR-OLD PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. ID (B)(6) : A (B)(6) YEAR-OLD PATIENT (BMI = 34.2) EXPERIENCED DIFFICULTY SWALLOWING SINCE SURGERY HAS IMPROVED; NECK PAIN AND NUMBNESS/ TINGLING DOWN ARMS; HAD COMPLAINTS O

  Patient problems: Pain

  MAUDE report 12036974 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) AND DUA DATA LISTING FOR THE ACIS RETROSPECTIVE STUDY COMPLETED AS PART OF THE PMCF PLAN. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS HAVE BEEN IDENTIFIED AS PER CARILLON CLINIC EMR - RETROSPECTIVE REVIEW: ID (B)(6): A (B)(6) YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. ID (B)(6): A (B)(6) YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYING DOWN; COMPLAINTS OF SOME ISSUES WITH SWALLOWING. ID (B)(6): A (B)(6) YEAR-OLD PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. ID (B)(6): A (B)(6) YEAR-OLD PATIENT (BMI = 34.2) EXPERIENCED DIFFICULTY SWALLOWING SINCE SURGERY HAS IMPROVED; NECK PAIN AND NUMBNESS/ TINGLING DOWN ARMS; HAD COMPLAINTS OF S

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 12036945 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) AND DUA DATA LISTING FOR THE ACIS RETROSPECTIVE STUDY COMPLETED AS PART OF THE PMCF PLAN. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS HAVE BEEN IDENTIFIED AS PER CARILLON CLINIC EMR - RETROSPECTIVE REVIEW: ID (B)(6): A (B)(6)-YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. ID (B)(6): A (B)(6)-YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYING DOWN; COMPLAINTS OF SOME ISSUES WITH SWALLOWING. ID (B)(6): A (B)(6)-YEAR-OLD PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. ID (B)(6): A (B)(6)-YEAR-OLD PATIENT (BMI = 34.2) EXPERIENCED DIFFICULTY SWALLOWING SINCE SURGERY HAS IMPROVED; NECK PAIN AND NUMBNESS/ TINGLING DOWN ARMS; HAD COMPLAINTS OF S

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 12036933 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) AND DUA DATA LISTING FOR THE ACIS RETROSPECTIVE STUDY COMPLETED AS PART OF THE PMCF PLAN. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS HAVE BEEN IDENTIFIED AS PER CARILLON CLINIC EMR - RETROSPECTIVE REVIEW: A (B)(6) FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. A (B)(6) PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYING DOWN; COMPLAINTS OF SOME ISSUES WITH SWALLOWING. A (B)(6) PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. A (B)(6) PATIENT (BMI = 34.2) EXPERIENCED DIFFICULTY SWALLOWING SINCE SURGERY HAS IMPROVED; NECK PAIN AND NUMBNESS/ TINGLING DOWN ARMS; HAD COMPLAINTS OF SOME TINGLING IN THE LEFT ARM THAT IS MOD AND INTERMITTENT NECK PAIN; CHRONIC AND

  Patient problems: Dysphagia/ Odynophagia; Muscular Rigidity

  MAUDE report 12036900 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) AND DUA DATA LISTING FOR THE ACIS RETROSPECTIVE STUDY COMPLETED AS PART OF THE PMCF PLAN. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS HAVE BEEN IDENTIFIED AS PER CARILLON CLINIC EMR - RETROSPECTIVE REVIEW: A (B)(6) FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. A (B)(6) PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYING DOWN; COMPLAINTS OF SOME ISSUES WITH SWALLOWING. A (B)(6) PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. A (B)(6) PATIENT (BMI = 34.2) EXPERIENCED DIFFICULTY SWALLOWING SINCE SURGERY HAS IMPROVED; NECK PAIN AND NUMBNESS/ TINGLING DOWN ARMS; HAD COMPLAINTS OF SOME TINGLING IN THE LEFT ARM THAT IS MOD AND INTERMITTENT NECK PAIN; CHRONIC AND

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 12033863 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA) FROM CARILION CLINIC. A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS PER IDENTIFIER HAVE BEEN IDENTIFIED AS FOLLOWS IN THE INITIAL REPORT: (B)(6): A 42-YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. (B)(6): A 45-YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING

  Patient problems: Pain

  MAUDE report 12032679 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA) FROM CARILION CLINIC. A TOTAL OF 50 PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH (B)(6): ACIS DEVICES (54%), FOLLOWED BY(B)(6): ACIS DEVICE (38%), AND (B)(6): ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS PER IDENTIFIER HAVE BEEN IDENTIFIED AS FOLLOWS IN THE INITIAL REPORT: ID (B)(6): A 42-YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. ID (B)(6): A 45-YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING;

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 12032363 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) AND DUA DATA LISTING FOR THE ACIS RETROSPECTIVE STUDY COMPLETED AS PART OF THE PMCF PLAN. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS HAVE BEEN IDENTIFIED AS PER CARILLON CLINIC EMR - RETROSPECTIVE REVIEW: ID (B)(6): A (B)(6) YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. ID (B)(6): A (B)(6) YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYING DOWN; COMPLAINTS OF SOME ISSUES WITH SWALLOWING. ID (B)(6): A (B)(6) YEAR-OLD PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. ID (B)(6): A (B)(6) YEAR-OLD PATIENT (BMI = 34.2) EXPERIENCED DIFFICULTY SWALLOWING SINCE SURGERY HAS IMPROVED; NECK PAIN AND NUMBNESS/ TINGLING DOWN ARMS; HAD COMPLAINTS OF S

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 12032145 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE USING VIVIGEN CELLULAR BONE MATRIX AT THE C5-C7 LEVELS ON (B)(6) 2017, WHERE THE PATIENT WAS IMPLANTED WITH A VECTRA PLATE, TWO SPACERS WITH CENTRAL LUMEN, A VIVIGEN POUCH AND A DISTRACTOR PIN. POST-OPERATIVELY, ON (B)(6) 2018, THE PATIENT HAD A FALL IN SHOWER THAT RESULTED IN HEADACHE, HIP PAIN, AND SMALL LACERATION. ON (B)(6) 2018, THE PATIENT PRESENTED AGAIN WITH HIP PAIN. CONCOMITANT DEVICE REPORTED: UNK - BIOLOGIC TISSUE MATRIX: VIVIGEN (PART # UNKNOWN, LOT UNKNOWN, QUANTITY 1); DISTRACTOR PIN 12MM (PART # 02.600.022, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) ACIS IMPLANT LORDOTIC/STANDARD. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 7864452 ↗