BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM BROAD DCP PLATE 6 HOLES/103MM

    MDR report key: 2931197 · Received January 28, 2013

    Report

    Report Number
    2520274-2013-00663
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 9, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 REPORTED AS UNKNOWN DAY IN (B)(6) 2008.

    Description of Event or Problem · 1

    PATIENT SUFFERED FROM A MIDSHAFT HUMERAL FRACTURE AND WAS IMPLANTED WITH PLATE AND SCREW CONSTRUCT, AT A DIFFERENT FACILITY, ON AN UNKNOWN DAY IN (B)(6) 2008. ON AN UNKNOWN DATE, POST-OPERATIVE X-RAYS SHOWED A NON-UNION. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. PATIENT WAS REVISED WITH TWO PLATES, AUTOGENOUS ILIAC CREST BONE GRAFT, AND LAG SCREW COMPRESSION. THIS IS 1 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37655 4.5MM BROAD DCP PLATE 6 HOLES/103MM DCP PLATE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention