BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEM EXTRACTOR

    MDR report key: 4442842 · Received January 20, 2015

    Report

    Report Number
    3005180920-2014-00212
    Event Type
    Malfunction
    Date Received
    January 20, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: STEM EXTRACTOR - SURGICAL INSTRUMENT: REF (B)(4) / LOT 1214019 ((B)(4) DEVICES PRODUCED). NO ANOMALIES FOUND; ALL THE OTHER ITEMS ARE IN USE IN THE WORLD. THE FAILURE MODE IS UNLIKELY TO CAUSE PATIENT HARM, EVEN IF IT CAN LEAD TO ADDITIONAL STEPS TO FIX THE PROBLEM.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45793 STEM EXTRACTOR SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1