BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMRS EXTENSION PIECE 60MM

    MDR report key: 1812924 · Received August 16, 2010

    Report

    Report Number
    9610726-2010-00260
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    KRO
    PMA / PMN Number
    K023087
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "OPENED THE IMPLANT FROM A LOANER KIT. OPENED THE SEALED OUTER PAK AND FOUND THE INNER PACKAGING OPENED. IMPLANT HAD SOME SORT OF DEBRIS ON IT AS WELL. USED ANOTHER PIECE OF THE SAME CAT NUMBER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMRS EXTENSION PIECE 60MM IMPLANT KRO STRYKER ORTHOPAEDICS LIMERICK NA LBAUO

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other