BEUDAMED
    FDA Adverse Event Other Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1884171 · Received October 13, 2010

    Report

    Report Number
    1030489-2010-01326
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUBMITTED PICTURES APPEAR TO SHOW TIP BROKEN OFF AT TRANSITION POINT. THE FRACTURE LOCATION AND APPEARANCE IS CONSISTENT WITH BEND STRESS OVERLOAD. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE X-RAYS CONFIRMED A PIECE OF METAL IN THE PT AFTER THE SURGERY. IT IS SUSPECTED TO BE A BROKEN TIP OF THE INSTRUMENT. NO OTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT STRAIGHT OSTEOTOME LXH MEDTRONIC SOFAMOR DANEK NA CT07E059

    Patients

    Seq Age Sex Outcome Treatment
    1 Other