BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR L LUMBAR STAND ALONE- CAGE 12 X 22 X 30 MM X 12 DEG

    MDR report key: 3850179 · Received June 5, 2014

    Report

    Report Number
    3005525032-2014-00071
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    OVD
    PMA / PMN Number
    K120869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RESULTS: THE PLAUSIBLE ROOT CAUSE OF THIS EVENT IS USER RELATED, SPECIFICALLY AN OVERLOAD APPLIED DURING INSERTION. IT SHOULD ALSO BE NOTED THAT THE INSERTER GUIDE WAS NOT USED TO INSERT THE SCREWS INTO THE CAGE WHICH IS NOT RECOMMENDED BY THE SURGICAL TECHNIQUE. CONCLUSION: THE ANCHOR L LUMBAR STAND ALONE- CAGE 12 X 22 X 30 MM X 12 DEG WAS CONFIRMED TO BE FRACTURE AS REPORTED UPON VISUAL INSPECTION. A 5 MINUTE DELAY WAS REPORTED (S0) AND NO OTHER HARMS. NO RELEVANT ISSUES WERE FOUND IN THE MANUFACTURING RECORDS OF THE DEVICE LOT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ANCHOR -L PEEK IMPLANT WOULD NOT HOLD LOCKING PLATE. SURGEON REMOVED IMPLANT AND INSPECTED AND NOTICED THAT THE IMPLANT WAS CHIPPED IN FRONT CORNER. THEREFORE THE SURGEON INSERTED ANOTHER ANCHOR L IMPLANT WITH RESCUE SCREWS AND ALL WENT WELL WITH COMPLETION OF CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ANCHOR -L PEEK IMPLANT WOULD NOT HOLD LOCKING PLATE. SURGEON REMOVED IMPLANT AND INSPECTED AND NOTICED THAT THE IMPLANT WAS CHIPPED IN FRONT CORNER. THEREFORE THE SURGEON INSERTED ANOTHER ANCHOR L IMPLANT WITH RESCUE SCREWS AND ALL WENT WELL WITH COMPLETION OF CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329790 ANCHOR L LUMBAR STAND ALONE- CAGE 12 X 22 X 30 MM X 12 DEG IMPLANT- LUMBAR CAGE SYSTEM OVD STRYKER SPINE-SWITZERLAND B27172

    Patients

    Seq Age Sex Outcome Treatment
    1