BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EIGHT-PLATE GUIDED GROWTH SYSTEM SCREW, 32MM

    MDR report key: 1260741 · Received December 10, 2008

    Report

    Report Number
    2183449-2008-00014
    Event Type
    Injury
    Date Received
    December 10, 2008
    Report Date
    December 10, 2008
    Manufacturer
    ORTHOFIX INC.
    Product Code
    HWC
    PMA / PMN Number
    K031493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SCREW BROKE ALONG THE THREAD DURING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EIGHT-PLATE GUIDED GROWTH SYSTEM SCREW, 32MM BONE SCREW, 32MM HWC ORTHOFIX INC. GP432 037C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention