BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2110708 · Received June 1, 2011

    Report

    Report Number
    1030489-2011-00644
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOWER JAW IS BROKEN OFF AT THE JAW PIVOT PIN. OPTICAL EXAMINATION DISCOVERED A FAIRLY BRITTLE FRACTURE. THE LOCATION, DIREC TION, AND AMOUNT OF FORCE REQUIRED IN ORDER INDUCE FRACTURE OF THE SHAFT IS CONSISTENT WITH APPLICATION OF EXCESSIVE FORCE. 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 INSTRUMENT BROKE AT THE MOUTH WHILE IN USE. ALTHOUGH THIS INSTRUMENT WAS USED DURING SURGERY, NO PATIENT CO MPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA GZ09A025

    Patients

    Seq Age Sex Outcome Treatment
    1