BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 2080005 · Received May 6, 2011

    Report

    Report Number
    1030489-2011-00509
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK MFG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE MICROPITUITARY INFERIOR SHAFT TIP IS CRACKED AT THE CENTER OF THE JAW PIVOT PIN, AND THE LOWER JAW IS BENT. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCES TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE PITUITARY WAS CRACKED. ALTHOUGH THE INSTRUMENT WAS USED TO TREAT A PATIENT, NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK MFG NA GZ06F153

    Patients

    Seq Age Sex Outcome Treatment
    1