BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 2080518 · Received May 6, 2011

    Report

    Report Number
    1030489-2011-00524
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK MFG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNCLEAR AT THIS TIME WHETHER THE DEVICE WAS DISCOVERED BEFORE SURGERY OR DURING SURGERY AND IT IS UNCLEAR AT THIS TIME WHETHER THE DEVICE WAS USED IN THE PATIENT OR NOT; THEREFORE WE ARE FILING THIS REPORT AS IF THE DEVICE WAS USED IN SURGERY, IN THE PATIENT. WE HAVE ATTEMPTED TO CONTACT THE REPORTER FOR CLARIFICATION. A FOLLOW UP REPORT WILL BE SENT WHEN CLARIFICATION IS RECEIVED. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 MICROPITUITARY WAS BROKEN. 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 GZ06K094

    Patients

    Seq Age Sex Outcome Treatment
    1