BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LCP DISTAL RADIUS PLATE VOLAR/RIGHT-LONG

    MDR report key: 1153258 · Received September 8, 2008

    Report

    Report Number
    1719045-2008-00114
    Event Type
    Injury
    Date Received
    September 8, 2008
    Report Date
    August 20, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K012114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED IMPLANT DATE IS 2008. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    AN LCP DISTAL RADIUS PLATE VOLAR IMPLANTED DURING AN ORIF RIGHT DISTAL RADIUS BROKE POSTOPERATIVELY. PATIENT COMPLAINED OF PAIN AND FOLLOW UP VISIT X-RAYS REVEALED A BROKEN PLATE. THE PLATE AND EIGHT (8) SCREWS WERE REMOVED AND PATIENT WAS REVISED TO ANOTHER PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LCP DISTAL RADIUS PLATE VOLAR/RIGHT-LONG DISTAL RADIUS PLATES HRS SYNTHES MONUMENT NA 2288035

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention SCREWS