BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF IMPLANT REMOVER

    MDR report key: 3737920 · Received March 27, 2014

    Report

    Report Number
    3005180920-2014-00032
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DOCUMENT REVIEW OF THE LOT INVOLVED (1112400 -(B)(4)ITEMS PRODUCED) NO ANOMALIES WERE FOUND. THE FAILURE MODE IS LIKELY TO CAUSE PT HARM, EVEN IF IT CAN LEAD TO ADD'L STEPS TO FIX THE PROBLEM.

    Description of Event or Problem · 1

    REF IMP # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181816 MECTALIF IMPLANT REMOVER REUSABLE SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1