BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1211269 · Received October 16, 2008

    Report

    Report Number
    1030489-2008-00571
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 16, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW UP REPORT IN RESPONSE TO USER FACILITY. THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR TREATMENT OF SCOLIOSIS. DURING THE PROCEDURE, WHILE THE SURGEON WAS USING THE FEELER PROBE AT T2, THE TIP OF THE INSTRUMENT WAS BROKEN OFF INSIDE THE PEDICLE. THE BROKEN PIECE WAS NOT RETRIEVED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other