ACIS 08.843.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034761640), received between Dec 15, 2017 and Jun 22, 2021 — classified as 10 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 10 most recent of 10 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 (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; Fatigue; Pain

  MAUDE report 12045638 ↗
• 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 12045625 ↗
• 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 (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: 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; STRANGLING FEE

  Patient problems: Discomfort

  MAUDE report 12042475 ↗
• 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 (B)(6) 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 LYING

  Patient problems: Pain

  MAUDE report 12037722 ↗
• 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 12037558 ↗
• 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 12037444 ↗
• 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 (B)(4) ACIS DEVICES (54%), FOLLOWED BY(B)(4) ACIS DEVICE (38%), AND (B)(4) 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: Pain

  MAUDE report 12037266 ↗
• InjuryJun 21, 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 PATIENTS

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 12037008 ↗
• 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 9MM HEIGHT. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 7864507 ↗
• InjuryDec 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TWO OR THREE LEVEL ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) AT THE C5-C7 LEVEL ON (B)(6) 2017. THE PATIENT WAS IMPLANTED WITH A VECTRA PLATE, TWO (2) VERTIGRAFT SPACERS WITH CENTRAL LUMEN, ONE (1) VIVIGEN POUCH, SIX (6) VECTRA SCREWS AND ONE (1) DISTRACTION PIN. REPORTEDLY, THE PATIENT EXPERIENCED ATRIAL FIBRILLATION ON (B)(6) 2017 AND WAS RESOLVED WITH NO RESIDUAL EFFECTS ON (B)(6) 2017. THE PATIENT WAS SCHEDULED TO HAVE CARDIOLOGY EVALUATION. ON (B)(6) 2017, THE PATIENT EXPERIENCED DIARRHEA AND ACUTE DIVERTICULITIS OF COLON AND WERE RESOLVED WITH NO RESIDUAL EFFECTS ON (B)(6) 2017. THE MEDICATIONS GIVEN WERE CIPRO AND FLAGYL. ON (B)(6) 2017, THE PATIENT WAS ADMITTED FOR A VOLUNTARY SURGERY TO CORRECT LUMBAR DEFORMITIES. DECOMPRESSIVE LUMBAR LAMINECTOMY L3-L4, 4-5, 5-1 BILATERAL FACETECTOMY, FORAMINOTOMY; HEMILAMINECTOMY, FACETECTOMY, FORAMINOTOMY, L2-3; AND POSTEROLATERAL ARTHRODESIS, L3-4, L4-5, L5-S1, ALLOGRAFT LOCAL AUTOGRAFT WERE ALSO DONE ON THE SAME DAY. THE PATIENT WAS DISCHARGED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT EXPERIENCED HEMATURIA. THE PATIENT WAS GIVEN KEFLEX AND FOLEY WAS FLUSHED AND CHANGED. THIS WAS RESOLVED WI

  Patient problems: No Code Available; Pain

  MAUDE report 7123697 ↗