BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2021311 · Received March 8, 2011

    Report

    Report Number
    2520274-2011-00038
    Event Type
    Injury
    Date Received
    March 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. MANUFACTURE SITE AND MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER. COULD NOT BE DETERMINED WITHOUT A CATALOG NUMBER. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PT REPORTED SHE IS DISABLED WITH POOR BALANCE AND LITTLE STRENGTH IN HER LEGS. ON AN UNK DATE, SHE FELL BACKWARDS WHILE AT HOME AND HIT HER ARM ON THE BED SUSTAINING AN EXTRA-ARTICULAR DISTAL HUMERAL FRACTURE OF THE RIGHT HUMERUS, FAIRLY COMMINUTED. PT REPORTED THAT SHE WAS IMPLANTED WITH AN UNK PLATE, 8 SCREWS AND 2 WIRES AND MAY HAVE BEEN IN A SLING AT SOME POINT POST-OP. PT ADVISED THAT 3 OF THE SCREWS BROKE AND WERE REMOVED DURING REVISION. THIS REPORT IS #1 OF 3 FOR THE SAME EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention WIRES| SCREWS| PLATE