BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1834487 · Received September 10, 2010

    Report

    Report Number
    1030489-2010-01161
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUF
    Product Code
    KWQ
    PMA / PMN Number
    K071416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO 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 TWO LEVEL ALIF PROCEDURE TO IMPLANT THE PLATE, THE PLATE HOLDER WAS HOLDING THE PLATE AND TWO POSITION PINS WERE PLACED ON THE PLATE. WHILE THE PLATE HOLDER WAS BEING REMOVED, A FRAGMENT OF THE TIP BROKE OFF. THE FRAGMENT WAS REMOVED VIA SUCTION. NO FRAGMENT WAS LEFT INSIDE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT PLATE HOLDER KWQ MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUF NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1