BEUDAMED
    FDA Adverse Event Other Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1821689 · Received August 27, 2010

    Report

    Report Number
    1030489-2010-01111
    Event Type
    Other
    Date Received
    August 27, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR FIXATION PROCEDURE AT T2-L2, THE BROKEN OFF PLUGS THAT WAS FOUND INSIDE OF THE RETAINING DRIVER WAS MORE THAN WHAT ACTUALLY BROKE OFF. THE PLUGS FROM THE PREVIOUS CASE MAY HAVE REMAINED IN THE DRIVER. NO PT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR SET SCREWS HEAD