BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2971298 · Received February 21, 2013

    Report

    Report Number
    2520274-2013-01094
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND 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 HAS A BILATERAL FEMUR FRACTURE AND BOTH FRACTURES WERE TREATED WITH SAME PLATE IMPLANTED APPROXIMATELY (B)(6) 2012 OR (B)(6) 2013. IT WAS DISCOVERED ON AN UNKNOWN DATE THAT ALL SCREWS LOOSEN INCLUDING CENTRAL HOLE WITH 4 PERIPHERAL VA SCREWS WERE INSERTED OFF AXIS AND THE MOST PROXIMAL HOLE ON THE HEAD OF THE PLATE WAS LEFT EMPTY. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013, ALL SCREWS WERE REMOVED AND THE PLATE WAS LEFT IN PLACE. PATIENT WAS REVISED TO A RETROGRADE FEMORAL NAIL WITH SPIRAL BLADE AND NEW LOCKING SCREWS WERE INSERTED IN THE PLATE. THE PLATE WAS NOT EXPLANTED. THIS IS 9 OF 11 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76676 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention