BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2840323 · Received November 20, 2012

    Report

    Report Number
    2520274-2012-03241
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 24, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING THE REMOVAL OF AN LCP WRIST FUSION PLATE AND 8 SCREWS, 2 OF WHICH WERE BROKEN AND ONE SCREW WAS NOT ENGAGED WITH THE PLATE, AS EVIDENCED BY X-RAY. THE INITIAL IMPLANT TOOK PLACE (B)(6) 2012. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH A NON-UNION OF THE WRIST FRACTURE. ON (B)(6) 2012, THE SURGEON EXPLANTED THE PLATE AND SCREWS AND REPLACED THEM WITH NEW A PLATE AND SCREWS. THIS IS REPORT #7 OF 9 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW SCREW HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention LCP WRIST FUSION PLATE