BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2771953 · Received September 28, 2012

    Report

    Report Number
    2520274-2012-02104
    Event Type
    Injury
    Date Received
    September 28, 2012
    Report Date
    August 29, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON GOING: NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR CATALOG NUMBER OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT HAD AN ULNAR DIAPHYSEAL FRACTURE. THE SURGEON WAS UNABLE TO REDUCE THE FRACTURE AND SUBSEQUENTLY EXCISED THE RADIAL HEAD THEN FIXED THE PART OF THE FRACTURE AFTER THE OSTEOTOMY. POSTOPERATIVELY, THE PLATE WAS NOTED AS BROKEN. REVISION SURGERY WAS PERFORMED THREE MONTHS AFTER THE INITIAL PROCEDURE. THE SURGEON WAS UNDER THE IMPRESSION THAT THE CONDITION OF THE REDUCTION AND INSERTION OF THE SCREW WERE NOT NORMAL. THE SURGEON BELIEVES THAT THE PLATE BROKE IN THE THIRD MONTH BECAUSE THE PLATE WAS NOT PROPERLY STABILIZED DUE TO THE EXCISING OF THE RADIAL HEAD. THE SURGEON THINKS THAT THE SCREW WAS INSERTED TOO CLOSELY AROUND THE PART OF THE FRACTURE. THIS IS THE 2ND OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention PLATE