BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP CC CUP IMPACTOR

    MDR report key: 3737899 · Received March 27, 2014

    Report

    Report Number
    3005180920-2014-00031
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS: FROM THE DOCUMENT REVIEW OF THE LOT INVOLVED (1110480 - (B)(4) IMPACTORS PRODUCED) NO ANOMALIES WERE FOUND. THE FAILURE MODE IS UNLIKELY TO CAUSE PT HARM, EVENT 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
    182550 VERSAFITCUP CC CUP IMPACTOR REUSABLE SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1