BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2935792 · Received January 30, 2013

    Report

    Report Number
    2520274-2013-00691
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 4, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AN INVESTIGATION AND DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO PART OR LOT NUMBER WAS PROVIDED AND THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES EU PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING A PLATE THAT BROKE POST OPERATIVELY. THE PLATE BROKE AT A SCREW HOLE WITH THE SCREW IN PLACE. THIS IS REPORT #1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40763 SCREW SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention