BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR WEDGED I/F CAGE(11X13)X13X25

    MDR report key: 2992437 · Received March 7, 2013

    Report

    Report Number
    1526439-2013-13299
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    March 26, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PPS960028/S8
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED CAGE FRAGMENTS FOUND TWO BROKEN PIECES, BOTH MEASURING APPROXIMATELY ¼" X ¼." THE PIECES WERE PLACED TOGETHER AND IMPACT DAMAGE WAS NOTED AROUND THE THREADED INSERTION HOLE. THREAD DAMAGE WAS ALSO NOTED. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS LOT CODE IS NOT CONTAINED ON THE RETURNED FRAGMENTS AND IS UNKNOWN. NO DEFINITIVE CONCLUSIONS CAN BE MADE. HOWEVER, THE OBSERVED DAMAGE SUGGESTS THAT THE CAGE MAY HAVE BEEN SUBJECTED TO A HIGHER THAN ANTICIPATED IMPACTION FORCE WHILE BEING INSERTED RESULTING IN DEVICE FRACTURE. IN THE ABSENCE OF AN OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND INVESTIGATED FURTHER.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE LUMBAR CAGE BROKE DURING INSERTION. REPORTS TWO-THIRDS OF THE CAGE WAS ALREADY IN THE DISC SPACE WHEN BREAKAGE OCCURRED AND COULD NOT BE REMOVED. THIS PORTION OF THE CAGE REMAINS IN THE PATIENT. AFFILIATE REPORTS THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98068 LUMBAR WEDGED I/F CAGE(11X13)X13X25 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1