BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLDING SLEEVE WITH LOCKING

    MDR report key: 2950092 · Received February 6, 2013

    Report

    Report Number
    1719045-2013-10045
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 8, 2011
    Report Date
    January 8, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TFN PROCEDURE, THERE WAS A MISALIGNMENT ISSUE. THE LOCKING SCREW WAS NOT LINING UP. THE JIG WAS REMOVED TO COMPLETE THE SURGERY FREE HAND. SURGERY TIME WAS EXTENDED LESS THAN ONE HOUR. THIS IS 10 OF 10 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50820 HOLDING SLEEVE WITH LOCKING HXX SYNTHES MONUMENT 6374125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention