BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT IMPACTION PLATE DML

    MDR report key: 8230884 · Received January 9, 2019

    Report

    Report Number
    3005180920-2018-01077
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    December 10, 2018
    Report Date
    January 9, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 JANUARY 2019: LOT 1654048: 21 ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENT HAS BEEN REPORTED ON THIS LOT. PRELIMINARY INVESTIGATION PERFORMED ON 08 JAN 2019 BY R&D PRODUCT MANAGER: THE PHOTOS SHOW THE PIECE WITH THE LOCKING COMPONENT SEPARATED FORM THE PLATE. THE EVENT CAN BE RELATED TO AN HIGH TORSION FORCE THAT COULD HAVE PROVIDED THE BREAKAGE OF THE LOCKING COMPONENT.

    Description of Event or Problem · 1

    DURING THE PRIMARY HIP SURGERY AND AFTER IMPACTING THE CUP, THE IMPACTION PLATE BROKE AND A FRAGMENT FELL INTO THE PATIENT AND WAS REMOVED. THERE WAS NO DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23594 MPACT IMPACTION PLATE DML SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1654048

    Patients

    Seq Age Sex Outcome Treatment
    1 Other