BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK MCO205A 0.3MM 90DEG POSTERIOR

    MDR report key: 3337536 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00131
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S.
    Product Code
    JYL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL OF THIS INSTRUMENT INDICATED THAT THE HOOK WAS RECEIVED BROKEN. NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC'S MXI FACILITY IN (B)(4). THIS REVIEW WAS CONDUCTED TO RESOLVE SEVERAL ISSUES DISCOVERED IN THE MXI COMPLAINT HANDLING PROCESS. ISSUES RESOLVED INCLUDE THE MISCLASSIFICATION OF DEVICES RETURNED FOR REPAIR, AS WELL AS GAPS IN REPORTING. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE (PART#: MCO205A) WAS RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424690 HOOK MCO205A 0.3MM 90DEG POSTERIOR JYL MEDTRONIC XOMED INSTRUMENTATION S.A.S. MCO205A 201006MF2

    Patients

    Seq Age Sex Outcome Treatment
    1