BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIABLE SELF-DRILLING SCREW DIAM. 4X14MM (2X)

    MDR report key: 6913762 · Received October 4, 2017

    Report

    Report Number
    3005180920-2017-00547
    Event Type
    Injury
    Date Received
    October 4, 2017
    Date of Event
    September 4, 2017
    Report Date
    October 4, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWQ
    UDI-DI
    07630030840005
    PMA / PMN Number
    K140361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS A SMOKER. ON 15 SEPTEMBER 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: 8 MONTHS AFTER ANTERIOR CERVICAL STABILIZATION THE PATIENT COMPLAINS OF PAIN. AT REVISION SURGERY, SOME SCREWS ARE FOUND TO BE BROKEN AND THE TWO INTERVERTEBRAL CAGES LOOSE. THE ABSENCE OF FUSION IS A POSSIBLE ADVERSE EVENT THAT MAY TAKE PLACE IN SUCH KIND OF SURGERY. IF FUSION DOES NOT OCCUR AND MOVEMENT IS PRESERVED, THE VERTEBRAL SCREWS ARE LIKELY TO BREAK. THE CAUSE FOR THIS LACK OF FUSION CANNOT BE DETERMINED WITH THE INFORMATION AT HAND. ON 15 SEPTEMBER 2017 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE AVAILABLE PICTURES, AND COMMENTED AS FOLLOWS: BASED ON THE PICTURE PROVIDED IT IS VERY DIFFICULT TO SEE IF FUSION TOOK PLACE. HOWEVER, THE SURGEON WAS ABLE TO IMPLANT 2X 1MM HIGHER CAGES ALMOST 10 MONTH AFTER THE PRIMARY SURGERY. THIS IS A STRONG INDICATION THAT FUSION DIDN'T TAKE PLACE. A SOLID FUSION IN THE CERVICAL SPINE USUALLY TAKE PLACE AFTER 3 MONTHS. THE NON OR DELAYED UNION IS FOR A HIGH PROBABILITY THE SOURCE FOR THE INPLANT FAILURE. BATCH REVIEW PERFORMED ON 02 OCTOBER 2017. LOT 1620210: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JULY 2016. EXPIRATION DATE: 2021-06-19. 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. MECTA-C CERVICAL INTERBODY FUSION DEVICE "DOME SHAPED" TIPEEK SIZE 12X14X5 L5°, CODE 03.28.702, LOT. 144006 (K142744) LOT 144006: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 FEBRUARY 2015. EXPIRATION DATE: 2020-01-31. 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. ON 03 OCTOBER 2017, THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: DURING THE VISUAL INSPECTION IT WAS OBSERVED THAT THREE OUT OF SIX SCREWS WERE BROKEN OFF IN THE MID PART OF THE SHAFT. BOTH THE TOP AND BOTTOM FOOTPRINT OF THE CAGES WAS FREE OF ANATOMICAL TISSUE. IT IS MOST LIKELY THAT THE DELAY AND/OR THE NON-FUSION OF THE CAGES GENERATED POTENTIAL STRESSES IN THE CROSS SECTION OF THE SCREWS. THE MECHANICAL BEHAVIOUR OF THE SCREWS IN TERM OF MECHANICAL RESISTANCE, WAS SUCCESSFULLY TESTED DURING THE VALIDATION PHASE TO PROVE CAN RESIST THE EXPECTED PHYSIOLOGICAL LOAD : TORSIONAL AND COMPRESSION TESTS WERE PERFORMED ON THE FINAL PLATE-SCREW CONSTRUCT TO INVESTIGATE ABOUT POTENTIAL FAILURE. ALL THE TESTS WERE PERFORMED ACCORDING TO THE STANDARDS IN FORCE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF CERVICAL PAIN. BONE SCAN AND CT SCAN WERE TAKEN, AND THE RESULTS SHOWED 2 BROKEN SCREWS ON C5 AND BONE SCAN IS POSITIVE ON C5-C6. 10 MONTHS AFTER PRIMARY THE SURGEON DECIDED TO REVISE THE PATIENT. 3 OF THE 6 PLATE SCREWS IMPLANTED IN PRIMARY WERE FOUND BROKEN (2 IN C5 AND 1 IN C7). IT WAS IMPOSSIBLE TO REMOVE THREE SCREWS DISTAL PART THAT REMAINED IN THE PATIENT. THE TWO CAGES WERE MIGRATED. IT WAS NOT POSSIBLE FOR THE SURGEON TO IMPLANT A NEW CERVICAL PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY BY INSERTING 2 NEW MECTA-C CAGES 1 MM THICKER THAN THE EXPLANTED. THE SURGEON COMMENTED THAT FUSION WAS DIFFICULT TO BE EVALUATED WITH THE TANTALUM MARKES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693378 VARIABLE SELF-DRILLING SCREW DIAM. 4X14MM (2X) SCREW FOR SPINAL FIXATION KWQ MEDACTA INTERNATIONAL SA 1620210 07630030840005

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention