BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM

    MDR report key: 3390241 · Received October 7, 2013

    Report

    Report Number
    2520274-2013-06672
    Event Type
    Injury
    Date Received
    October 7, 2013
    Date of Event
    September 10, 2013
    Report Date
    September 10, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES KTT.

    Description of Event or Problem · 1

    PATIENT WAS INITIALLY INJURED ON (B)(6) 2012. PATIENT SUSTAINED A RADIAL FRACTURE, DISTAL RADIUS FRACTURE, ULNAR SHAFT FRACTURE AND DISTAL ULNAR FRACTURE WHEN HE WAS DRUNK, PASSED OUT ON THE ROAD AND A TRUCK RAN OVER HIS ARM. PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2012. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE DUE TO NON-UNION. PATIENT WAS REVISED TO NEW HARDWARE WITH ILIAC CREST BONE GRAFT. ALL HARDWARE REMOVED WAS INTACT. THIS IS REPORT 9 OF 9 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505539 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention