BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP RECONSTRUCTION PLATE 7 HOLES/98MM

    MDR report key: 1003269 · Received February 27, 2008

    Report

    Report Number
    1719045-2008-00016
    Event Type
    Injury
    Date Received
    February 27, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 6, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A 3.5MM LCP RECONSTRUCTION PLATE WAS IMPLANTED FOR AN ORIF OF THE ULNA AND RADIUS. A POST-OPERATIVE X-RAY VERIFIED GOOD ANATOMICAL ALIGNMENT. PT RETURNED TO THE SURGEON COMPLAINING OF PAIN. AN X-RAY SHOWED INTERNAL BENDING OF THE PLATE. PLATE AND SIX SCREWS WERE REMOVED AND A SECONDARY ORIF WAS PERFORMED, AND HARDWARE WAS REPLACED WITH A PLATE AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LCP RECONSTRUCTION PLATE 7 HOLES/98MM RECONSTRUCTION PLATES HRS SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCREWS