BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS

    MDR report key: 2853349 · Received November 30, 2012

    Report

    Report Number
    1719045-2012-01219
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 4, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 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

    PATIENT IMPLANTED WITH FEMORAL NAIL AND SCREWS ON (B)(6) 2012. IT WAS DISCOVERED THE PATIENT DID NOT HEAL. SURGEON RETURNED PATIENT TO OR ON (B)(6) 2012, THE HARDWARE WAS REMOVED, PATIENT WAS REVISED TO ANOTHER NAIL AND SCREWS. THIS IS 4 OF 4 REPORTS FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS LOCKING SCREW HSB SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention NAIL, SCREWS