BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIGHT-PLATE GUIDED GROWTH SYSTEM SCREW, 24MM

    MDR report key: 1422636 · Received April 20, 2009

    Report

    Report Number
    2183449-2009-00006
    Event Type
    Malfunction
    Date Received
    April 20, 2009
    Date of Event
    March 25, 2009
    Report Date
    April 17, 2009
    Manufacturer
    ORTHOFIX INC.
    Product Code
    HWC
    PMA / PMN Number
    K031493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROVIDED INFORMATION STATES THE BROKEN PART OF THE SCREW WAS LEFT IN THE PT BONE. REMAINDER OF SCREW WAS RETURNED TO THE MANUFACTURER (ORTHOFIX INC) FOR EVALUATION.

    Description of Event or Problem · 1

    PROVIDED INFORMATION STATES THAT DURING REMOVAL ACTIVITIES, THE DISTAL SCREW BROKE ALONG THREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EIGHT-PLATE GUIDED GROWTH SYSTEM SCREW, 24MM BONE SCREW, 24MM HWC ORTHOFIX INC. GP224 047C

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR