BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES USA

    MDR report key: 172444 · Received June 10, 1998

    Report

    Report Number
    172444
    Event Type
    Injury
    Date Received
    June 10, 1998
    Date of Event
    March 12, 1998
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEFT HIP SCREW BROKE AND NEEDED TO BE REPLACED FROM A 1996 SURGERY (A LEFT HIP SLIPPED CAPITAL FEMORAL EPIPHYSIS). ANOTHER SCREW WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES USA Implant 7 MM CANNULATED SCREW HWC SYNTHES (USA) 7MM SCREW-#208.050-16MM THREAD 8-6-96-1-3

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention