BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2901132 · Received January 8, 2013

    Report

    Report Number
    2520274-2013-00107
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    February 27, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. IMPLANT DATE APPROXIMATELY (B)(6) 2011.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH LISS PLATE AND SCREW CONSTRUCT TO TREAT A FEMUR FRACTURE, ON AN UNKNOWN DATE, ABOUT (B)(6) 2011. ON AN UNKNOWN DATE, THE POST-OPERATIVE X-RAYS REVEALED A MAL-UNION. ON (B)(6) 2012 PATIENT RETURNED TO THE OPERATING ROOM AND ALL HARDWARE WAS EXPLANTED. DURING THIS PROCEDURE, THE SCREW DRIVER THE SURGEON WAS USING BROKE, AND THE TIP OF IT STAYED IN THE HEAD OF THE SCREW. PATIENT WAS ALSO TREATED FOR POSSIBLE INFECTION. THIS IS 11 OF 12 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9499 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention PLATE, SCREWS