BEUDAMED
    FDA Adverse Event Other Summary report: N

    GAP PLATE SCREWS

    MDR report key: 1427582 · Received April 7, 2009

    Report

    Report Number
    2249697-2009-00176
    Event Type
    Other
    Date Received
    April 7, 2009
    Date of Event
    March 11, 2009
    Report Date
    March 11, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K943549
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MORE GAP PLATE SCREW CATALOG # 2080-0025, LOT CODE N0RMNE, STERILE LOT MSHEN25 MANUFACTURED ON SEPTEMBER 25, 2008 WAS LISTED IN THIS REPORT. NONE OF THEM WAS DETERMINED TO CAUSE OR CONTRIBUTED TO THE REPORTED EVENT. DHR AND TRITANIUM PRIMARY SURGICAL PROTOCOL REVIEW PERFORMED. SUMMARY OF EVAL: THE RESULTS OF THE INVESTIGATION INDICATE THAT THE USE OF THE GAP SCREWS DURING THE IMPLANTATION OF THE TRITATNIUM PRIMARY SYSTEM WAS CONTRAINDICATED ACCORDING TO THE TRITANIUM PRIMARY SURGICAL PROTOCOL. AN EVAL OF THE REPORTED SCREWS CANNOT BE PERFORMED AS THEY REMAINED IMPLANTED IN THE PT AND WERE NOT RETURNED TO THE MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "GAP CUP SCREWS USED WITH TRITANIUM PRIMARY CUP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAP PLATE SCREWS IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA METJ6W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other