BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OFFSET ADAPTER

    MDR report key: 824956 · Received March 7, 2007

    Report

    Report Number
    9610726-2007-00008
    Event Type
    Injury
    Date Received
    March 7, 2007
    Date of Event
    October 30, 2006
    Report Date
    November 16, 2006
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    FJP
    PMA / PMN Number
    K973164
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD TO UNDERGO A REVISION AS THE OFFSET BOLT HAD SNAPPED AT THE HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OFFSET ADAPTER IMPLANT FJP STRYKER ORTHOPAEDICS LIMERICK NA MAR199A

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention