BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCULIF TL 10-16 MM X 11 MM X 34 MM X 0 DEG CAGE

    MDR report key: 5480396 · Received March 4, 2016

    Report

    Report Number
    0009617544-2016-00095
    Event Type
    Injury
    Date Received
    March 4, 2016
    Date of Event
    February 9, 2016
    Report Date
    February 9, 2016
    Manufacturer
    STRYKER SPINE-US
    Product Code
    MAX
    PMA / PMN Number
    K143616
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG# 305010, LOT# 0791401. METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: A MANUFACTURING REVIEW WAS PERFORMED ON BOTH DEVICES AND INDICATED NO DISCREPANCIES OR ANOMALIES. THE IMPLANTS WERE NOT RETURNED FOR EVALUATION, HOWEVER INTRA-OP X-RAY IMAGES AND EXPLANTED DEVICE IMAGES WERE PROVIDED. BASED ON THESE IMAGES THE TWO REVISED CAGES ARE STILL EXPANDED TO APPROXIMATELY THE SAME HEIGHT AS THEY WERE EXPANDED INTRA OPERATIVELY CONCLUSION: FAILURE OF THE IMPLANTS CANNOT BE CONFIRMED. IMAGES PROVIDED BY THE PATIENT SHOW THAT BOTH REVISED IMPLANTS ARE STILL EXPANDED TO ABOUT THE SAME HEIGHT AS THEY WERE EXPANDED INTRA-OPERATIVELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED AND DESCRIBED THE FOLLOWING EVENT: HE HAD A PRIMARY SURGERY ON (B)(6) 2015. THE SURGERY TOOK 7 HOURS. IT WAS A 2 LEVEL FUSION FIXATION. 1 MONTH AFTER PROCEDURE, PATIENT NOTICED THAT THE LOWER RIGHT SCREW HAD BACK OUT. EIGHT MONTHS LATER, PATIENT WENT TO A HOSPITAL AND IT WAS IDENTIFIED THAT THE LOWER IMPLANT HAD MIGRATED. HE MENTIONED THAT HE BELIEVES THAT THE TOP IMPLANT HAS ALSO MIGRATED. PATIENT HAS RIGHT LEG AND RIGHT HIP PAIN AND BOWEL MOVEMENT ISSUES. PATIENT DOES HAVE A LAWYER BUT IT IS SOLELY DUE TO THE PROCEDURE AND THE OPERATING SURGEON AT THIS TIME, NOT AGAINST STRYKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED AND DESCRIBED THE FOLLOWING EVENT: HE HAD A PRIMARY SURGERY ON (B)(6) 2015. THE SURGERY TOOK 7 HOURS. IT WAS A 2 LEVEL FUSION FIXATION. 1 MONTH AFTER PROCEDURE, PATIENT NOTICED THAT THE LOWER RIGHT SCREW HAD BACK OUT. 8 MONTHS LATER PATIENT WENT TO A HOSPITAL AND IT WAS IDENTIFIED THAT THE LOWER IMPLANT HAD MIGRATED. HE MENTIONED THAT HE BELIEVES THAT THE TOP IMPLANT HAS ALSO MIGRATED. PATIENT HAS RIGHT LEG AND RIGHT HIP PAIN AND BOWEL MOVEMENT ISSUES. PATIENT DOES HAVE A LAWYER BUT IT IS SOLELY DUE TO THE PROCEDURE AND THE OPERATING SURGEON AT THIS TIME, NOT AGAINST STRYKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137964 ACCULIF TL 10-16 MM X 11 MM X 34 MM X 0 DEG CAGE INTERVERTEBRAL BODY FUSION DEVICE MAX STRYKER SPINE-US 0791401

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention