BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET ADAPTER 8MM

    MDR report key: 1082420 · Received July 21, 2008

    Report

    Report Number
    9610726-2008-00043
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 19, 2008
    Manufacturer
    STRYKER OTHOPAEDICS LIMERICK
    Product Code
    HSH
    PMA / PMN Number
    K910500
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY PROCEDURE, CONNECTING THE OFFSET ADAPTER WITH THE TIBIA, SURGEON NOTED THAT THE THREAD OF THE ADAPTER SHEARED OFF. AS NO OTHER IMPLANT WAS AVAILABLE, THE SURGEON USED A SMALLER IMPLANT AND COMPLETED THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OFFSET ADAPTER 8MM IMPLANT HSH STRYKER OTHOPAEDICS LIMERICK NA 157763

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other