BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACDF MECTA-C SA DRILL SCREW LOCK 3.8X14 (2X)

    MDR report key: 11594893 · Received March 31, 2021

    Report

    Report Number
    3005180920-2021-00261
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    March 6, 2021
    Report Date
    May 5, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVE
    UDI-DI
    07630040726603
    PMA / PMN Number
    K192906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SURGEON COMMENT: THE SURGEON MENTIONED THAT 10 DAYS POST-OP THE PATIENT WAS WITHOUT COMPLICATIONS. HOWEVER, THE COMPLICATION STARTED WITHIN 24 HOURS AFTER THE PHYSIOTHERAPY, THAT THE TIME POINT WHERE THEY DID THE 3 WEEK POST OP CT SCAN, DETECTED THE MIGRATED SCREW AND PERFORMED THE REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27-MAR-2021: LOT 1923963: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-APR-2020. EXPIRATION DATE: 2025-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DIRECTOR: FEW DAYS AFTER BI-LEVEL CERVICAL STABILIZATION SURGERY, ONE OF THE PLATE FIXATION SCREWS MIGRATED AND PERFORATED THE ESOPHAGUS, WHICH REQUIRED URGENT REOPERATION. FROM THE POSTOPERATIVE IMAGES, IT SEEMS THAT THE MIGRATED SCREW NEVER REACHED THE FINAL CORRECT POSITION, IT MAY HAVE BEEN INSERTED AT AN ANGLE THAT DID NOT ALLOW THE PLATE'S THREAD TO BE PROPERLY ENGAGED. THIS WAS PROBABLY ALSO DUE TO THE RATHER SCLEROTIC BONE. THIS HYPOTHESIS IS ALSO CONFIRMED BY THE FACT THAT THE TORQUE LIMITING DEVICE OPENED BEFORE THE SCREW WAS FINALLY INSERTED. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: IT WAS OBSERVED THAT THE BEGINNING OF THE THREAD OF THE SCREW, BELOW THE HEAD, IS DEFORMED. IT IS BENT TOWARDS THE HEAD AND THERE IS A LOSS OF ANODIZATION IN THE INFERIOR PART OF THE THREAD. TESTS WERE PERFORMED ON A SIMILAR SCREW AND IT WAS NOTED THAT IT DEFORMED (AS PREVIOUSLY DESCRIBED) WHEN IT WAS NOT FULLY SEATED IN THE PLATE. FOLLOWING THESE RESULTS, IN CONJUNCTION WITH ANALYSIS OF XRAYS AND PROVIDED PICTURE, IT IS POSSIBLE TO HYPOTHESIZE THAT THE ROOT CAUSE OF THE COMPLAINT COULD BE DUE TO THE NOT CORRECT TIGHTENING OF THE MIGRATED SCREW.

    Description of Event or Problem · 1

    3 WEEKS AFTER THE PRIMARY SURGERY THE PATIENT HAD SEVERE CERVICAL SPINE PAIN, IT WAS RECOGNISED THAT ONE OF THE THREE PLATE SCREWS WAS TOTALLY UNSCREWED. THE PATIENT WAS REVISED IMMEDIATELY, REMOVING THE SCREW. DURING SURGERY IT WAS DISCOVERED THAT THE ESOPHAGUS WAS PERFORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491950 ACDF MECTA-C SA DRILL SCREW LOCK 3.8X14 (2X) ANTERIOR VERTEBRAL FIXATION SCREW OVE MEDACTA INTERNATIONAL SA 03.18.622 1923963 07630040726603

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention