ACIS 08.843.008SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034761633), received between Jun 21, 2021 and Jun 22, 2021 — classified as 5 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 5 most recent of 5 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

  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 LYING

  Patient problems: Dysphagia/ Odynophagia; Muscular Rigidity

  MAUDE report 12043761 ↗
• 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: Pain

  MAUDE report 12043603 ↗
• 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 (B)(6) CLINIC EMR - RETROSPECTIVE REVIEW: (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. (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. (B)(6) PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. (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 MODERATE

  Patient problems: Nerve Damage; Numbness; Pain

  MAUDE report 12037480 ↗
• 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)(6): 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 SWALLO

  Patient problems: Pain

  MAUDE report 12036569 ↗
• 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 (B)(6) 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: Dysphagia/ Odynophagia

  MAUDE report 12033583 ↗