BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORATION MODULAR PROXIMAL BODY BOLT

    MDR report key: 1112507 · Received August 7, 2008

    Report

    Report Number
    9616680-2008-00230
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE FINAL TIGHTENING ON THE BOLT WITH A TORQUE WRENCH, THE BOLT SNAPPED OFF AT THE PROXIMAL BODY STEM FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION MODULAR PROXIMAL BODY BOLT IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA CAXE606

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other