BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW 42MM- FOR IM NAILS

    MDR report key: 3003102 · Received March 13, 2013

    Report

    Report Number
    1719045-2013-00551
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 19, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    PATIENT WAS IMPLANTED WITH TFN ON (B)(6) 2012. ON AN UNKNOWN POST-OPERATIVE DATE, IT IS REPORTED THAT THE TFN CUT OUT OF THE FEMORAL NECK AND HEAD. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REVISION SURGERY. SURGEON EXPLANTED THE TFN AND REVISED PATIENT WITH BIPOLAR HIP REPLACEMENT. IT IS REPORTED THAT SURGERY WAS A SUCCESS. THIS IS 3 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105207 5.0MM TI LOCKING SCREW 42MM- FOR IM NAILS HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention