BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW SELF-DRILLING

    MDR report key: 765451 · Received September 28, 2006

    Report

    Report Number
    1719045-2006-00095
    Event Type
    Injury
    Date Received
    September 28, 2006
    Report Date
    August 30, 2006
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    SOME SCREWS, IMPLANTED IN A LISS PLATE WITH ALLOGRAFT/BMP BONE GRAFT ON THE LEFT FEMUR FOR A PERIPROSTHETIC SUPRACONDYLAR FEMUR FRACTURE, WERE NOTED AS BROKEN POST OPERATIVELY. ALL HARDWARE WAS REMOVED AND REPLACED WITH A CONDYLAR PLATE. PATIENT WAS REPORTEDLY NONCOMPLIANT WITH NWB INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM TI LOCKING SCREW SELF-DRILLING LOCKING SCREWS HRS SYNTHES (USA) NA 2110225

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention BONE GRAFT| PLATE