BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EIGHT PLATE SCREW, 32MM

    MDR report key: 873356 · Received June 29, 2007

    Report

    Report Number
    2183449-2007-00015
    Event Type
    Injury
    Date Received
    June 29, 2007
    Date of Event
    May 11, 2007
    Report Date
    June 29, 2007
    Manufacturer
    ORTHOFIX INC.
    Product Code
    HRS
    PMA / PMN Number
    K031493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DISTAL (METAPHYSEAL) EIGHT PLATE SCREW BROKE DURING TREATMENT. THE DOCTOR REPLACED THE BROKEN SCREW WITH ANOTHER EIGHT PLATE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EIGHT PLATE SCREW, 32MM EIGHT PLATE BONE SCREW, 32MM HRS ORTHOFIX INC. GP432 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention