BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX FLEX ARM

    MDR report key: 2940412 · Received February 3, 2013

    Report

    Report Number
    1030489-2013-00357
    Event Type
    Malfunction
    Date Received
    February 3, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE, TWO INSTRUMENTS BROKE. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45717 METRX FLEX ARM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1