BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORS DIST RADIUS-LT NAR

    MDR report key: 467674 · Received June 25, 2003

    Report

    Report Number
    1818910-2003-00363
    Event Type
    Injury
    Date Received
    June 25, 2003
    Date of Event
    May 22, 2003
    Report Date
    May 27, 2003
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HRS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT'S WRIST IMPLANT BROKE AND IT HAD TO BE REVISED. ORIGINAL INJURY OCCURRED DURING ROLLERBLADING. THE ORIGINAL BREAK DID NOT HEAL CORRECTLY SO THE DR. REBROKE THE WRIST; USED CADAVER BONE AND APPLIED THE BONE PLATE. THEY DISCOVERED IT HAD BROKEN WHEN THE CAST CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORS DIST RADIUS-LT NAR TRAUMA HRS DEPUY ACE S.A. 'R.L. NA V03840

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention