BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED SCREW ASNIS III Ø6.5X105MM TL20MM

    MDR report key: 3191907 · Received June 27, 2013

    Report

    Report Number
    0008031020-2013-00205
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K000080
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION IS AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD 3 CANULATED SCREWS IMPLANTED IN THE FEMORAL HEAD. THE FEMORAL HEAD FRACTURED, SO THE SURGEON REVISED TO A TOTAL HIP. REMOVED THE SCREWS ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293729 CANNULATED SCREW ASNIS III Ø6.5X105MM TL20MM IMPLANT HWC STRYKER OSTEOSYNTHESIS-SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention