BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1041218 · Received May 8, 2008

    Report

    Report Number
    1030489-2008-00226
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MEDTRONIC WHERE VISUAL EXAMINATION FOUND THAT THE DRILL IS BROKEN AT THE ROOT OF THE FLUTING WHICH IS THE SECTION SUBJECTED TO THE HIGHEST LOADING LEVELS. THE OBSERVATION OF THE FRACTURE APPEARANCE SHOWS A DUCTILE FRACTURE WHERE THE DRILL FIRST UNTWISTED BEFORE THE ULTIMATE MATERIAL STRENGTH WAS EXCEEDED. THE OUTSIDE DIAMETER OF THE DRILL MEASURED WITHIN SPECIFICATIONS. NO DEFECT WAS OBSERVED THAT WOULD CONTRIBUTE TO A WEAKENING OF THE PART. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. EXAMINATION OF POST-OP LATERAL X-RAY REVEALS ARTIFICIAL DISC IN GOOD POSITION AT C5-6 WITH FRAGMENT OF BIT IN THE BODY OF C6.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE CERVICAL SPINE FOR IMPLANT OF THE ARTIFICIAL DISC THE TIP OF THE RAIL CUTTER BIT WAS BROKEN OFF INTO THE VERTEBRAL BODY. IT WAS REPORTED THAT 5 MM OF THE INSTRUMENT REMAINS IN THE C6 VERTEBRAL BODY. NO PT COMPLICATIONS WERE REPORTED. NO REVISION SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT RAIL CUTTER BIT LXH MEDTRONIC SOFAMOR DANEK MANUFACTURING NA NG04L004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK