BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01358

    MDR report key: 3001309 · Received March 13, 2013

    Report

    Report Number
    2520274-2013-01358
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 12, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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.

    Description of Event or Problem · 1

    PATIENT SUFFERED FROM FOREARM FRACTURE AND HAD AN ORIF ON AN UNKNOWN DATE. PATIENT WAS IMPLANTED WITH A PLATE AND SIX SCREWS ON THE RADIUS. POST-OPERATIVELY, ON AN UNKNOWN DATE, PATIENT FELL AND RE-INJURED HIMSELF, FRACTURING THE RADIUS AS WELL AS THE PLATE. PLATE BROKE AT THE MOST PROXIMAL SCREW HOLE. THE PLATE BROKE BUT THE SIX SCREWS WERE INTACT AND UNBROKEN IN THE RADIUS. PATIENT RETURNED TO THE OR ON (B)(6) 2013 FOR REVISION SURGERY. SURGEON REMOVED THE BROKEN PLATE AND SIX SCREWS AND REVISED PATIENT WITH A TEN HOLE PLATE AND SIX SCREWS. REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105953 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention