BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF TRANSFORAMINAL CAGE 12X30X9 L5

    MDR report key: 4878425 · Received June 26, 2015

    Report

    Report Number
    3005180920-2015-00135
    Event Type
    Injury
    Date Received
    June 26, 2015
    Report Date
    October 1, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MAX
    PMA / PMN Number
    K131671
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 JUNE 2015: LOT 111748: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 DEC 2011. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 15 JUNE 2015 IT WAS REPORTED THAT: FOR THAT CASE, THE SURGEON HAD TO PERFORM A 2 LEVELS TRANSFORAMINAL CASE. FOR THE 1ST LEVEL, HE MANAGED TO INSERT THE CAGE BUT COULDN'T DO IT IN A SATISFACTORY MANNER. AFTER PARTIAL INSERTION, THE PRESSURE ON THE CAGE MADE IT NOT POSSIBLE TO BE MOVED OR ROTATED ANYMORE. THE SURGEON DECIDED TO LEFT THE CAGE IN PLACE BUT WAS NOT TOTALLY SATISFIED WITH ITS FINAL POSITION. FOR THE 2ND LEVEL, HE DECIDED TO USE A CAGE OF A COMPETITOR.

    Additional Manufacturer Narrative · 1

    ON 01 SEPTEMBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DAY THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415727 MECTALIF TRANSFORAMINAL CAGE 12X30X9 L5 TRANSFORAMINAL PEEK CAGE MAX MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1