BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW

    MDR report key: 2832020 · Received November 14, 2012

    Report

    Report Number
    2520274-2012-02973
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    May 31, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE DATE OF IMPLANT IS (B)(6) 2010. INVESTIGATION IS ON-GOING; INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO CATALOG OR LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT SUFFERED AN OPEN FRACTURE OF THE LEFT LEG AND WAS IMPLANTED WITH A NAIL AND SCREW CONSTRUCT IN (B)(6) 2010. PATIENT EXPERIENCED SUBSEQUENT INFECTION OF THE LEFT LEG AND A NON-UNION. HARDWARE WAS EXPLANTED (B)(6) 2012, ALONG WITH AMPUTATION. REPORTEDLY, PATIENT WAS NON COMPLIANT. THERE ARE A TOTAL OF 6 REPORTS FOR THIS SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW LOCKING SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NAIL, END CAP