BEUDAMED
    FDA Adverse Event Other Summary report: N

    GAP PLATE SCREWS

    MDR report key: 1471374 · Received September 3, 2009

    Report

    Report Number
    2249697-2009-00563
    Event Type
    Other
    Date Received
    September 3, 2009
    Date of Event
    July 28, 2009
    Report Date
    July 28, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K943549
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. USERS FAILED TO FOLLOW INSTRUCTIONS. NO ADDITIONAL INFORMATION TO REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BONE SCREW THAT WAS PART OF A RECALL, WAS IMPLANTED IN A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAP PLATE SCREWS IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH MA MERMH7

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK