ACIS 08.843.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034761701), received between Jun 21, 2021 and Jun 22, 2021 — classified as 2 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 2 most recent of 2 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 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 - T

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 12041830 ↗
• 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 12037507 ↗