BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3832143 · Received February 14, 2014

    Report

    Report Number
    3025141-2014-00010
    Event Type
    Injury
    Date Received
    February 14, 2014
    Report Date
    January 17, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MDRS ASSOCIATED WITH THIS EVENT: 3025141-2014-00011: PLATE.

    Description of Event or Problem · 1

    AFTER PERFORMING A DISTAL RADIUS OSTEOTOMY AND IMPLANTING A DISTAL RADIAL PLATE WITH SCREWS, PEGS AND BONE GRAFT SUBSTITUTE, THE HEADS OF THE SCREWS AND PEGS FROM THE DISTAL ROW OF THE PLATE BROKE OFF POST OPERATIVELY. THE SCREWS, PEGS AND PLATE WERE REMOVED AND WERE REPLACED WITH A NEW PLATE, SCREWS, PEGS AND BONE GRAFT SUBSTITUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98081 SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention