BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE REDUCTION WIRE 01.25 W/LARGE STOP

    MDR report key: 2902485 · Received January 8, 2013

    Report

    Report Number
    8030965-2012-01493
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVAL PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFO FROM A FACILITY IN (B)(6) REGARDING PLATE REDUCTION WIRES. DURING THE SURGICAL PROCEDURE, 2 OF 3 WIRES BROKE UPON INSERTION AND 2 OF THE 3 BROKE DURING REMOVAL. THE WIRE BROKE JUST ABOVE THE LARGE EXPANSION. IT WAS NOTED THAT THE BONE QUALITY WAS MEDIUM. THIS REPORT #1 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9642 PLATE REDUCTION WIRE 01.25 W/LARGE STOP PLATE REDUCTION WIRE HRS SYNTHES GMBH 7824711

    Patients

    Seq Age Sex Outcome Treatment
    1