BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.14 MM

    MDR report key: 7487004 · Received May 4, 2018

    Report

    Report Number
    3005180920-2018-00302
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    April 6, 2018
    Report Date
    May 4, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    UDI-DI
    07630030833564
    PMA / PMN Number
    K124034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 MAY 2018. LOT 143313: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JUNE 2015, EXPIRATION DATE: 2020-06-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE: (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. INSTRUMENTS INVOLVED: MECTALIF REFERENCE (B)(4) ALIF STRAIGHT INSERTER MECTALIF REFERENCE (B)(4) ALIF INSERTER INNER SHAFT PRELIMINARY INVESTIGATION PERFORMED BY R&D SPINE DIRECTOR ON 10 APRIL 2018. THE INSTRUMENT IS DESIGNED THAT THE PINS OF THE INSTRUMENT GO THROUGH THE PLATE INTO THE CAGE, FOR THIS REASON WITH THE AVAILABLE INFORMATION IT IS NOT POSSIBLE UNDERSTAND WHAT COULD HAVE HAPPENED DURING SURGERY.

    Description of Event or Problem · 1

    AFTER IMPLANTATION OF A MECTALIF TI PEEK ANTERIOR CAGE WITH FLUSH PLATE, THE SURGEON WAS ATTEMPTING TO CHANGE THE ROTATIONAL POSITION OF THE CAGE WITHIN THE DISC SPACE TO MATCH THE ANATOMY. THE FLUSH PLATE BECAME DISASSOCIATED FROM THE CAGE. A SECOND CAGE AND FLUSH PLATE WAS OPENED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331450 MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.14 MM PLATE FLUSH OVD MEDACTA INTERNATIONAL SA 143313 07630030833564

    Patients

    Seq Age Sex Outcome Treatment
    1 Other