BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW 34MM- FOR IM NAILS

    MDR report key: 2854734 · Received December 3, 2012

    Report

    Report Number
    1719045-2012-01243
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    NON-AMBULATORY PATIENT WAS IMPLANTED WITH TFN CONSTRUCT ON (B)(6) 2012. PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF HARDWARE AND NO REVISION. THE HELICAL BLADE HAD CUT THROUGH THE FEMORAL HEAD. PATIENT WAS RECEIVING PHYSICAL THERAPY AT NURSING FACILITY. THE BLADE MIGRATED DURING THAT TIME. SURGEON REPORTS TFN CUTOUT DUE TO POOR BONE QUALITY AND AGGRESSIVE PHYSICAL THERAPY. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM TI LOCKING SCREW 34MM- FOR IM NAILS LOCKING SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention NAIL AND HELICAL BLADE