BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTA-C CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)

    MDR report key: 5369905 · Received January 15, 2016

    Report

    Report Number
    3005180920-2015-00388
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    December 17, 2015
    Report Date
    April 15, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWQ
    PMA / PMN Number
    K140361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 JANUARY 2016: LOT 141365: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 OCTOBER 2014. EXPIRATION DATE: 2019-06-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 15 JAN 2016 THE MEDICAL AFFAIRS MADE THE FOLLOWING ANALYSIS, WHILE CHECKING THE X-RAYS: CERVICAL SCREWS ARE VERY SMALL FOR ANATOMICAL REASONS. IT IS POSSIBLE THAT, AS THE ASSISTANT AT THE OPERATION REPORTED, EVEN IN THE HANDS OF MOST EXPERIENCED SURGEONS A SMALL DEVIATION FROM THE AXIS MAY HAPPEN, PARTICULARLY IN PATIENTS WITH GOOD BONE QUALITY, AND THEREFORE THE SCREW HEAD WILL HIT THE PLATE AND, IF EXCESSIVE TORQUE IS APPLIED IN THE ATTEMPT TO MAKE THE SCREW FLUSH WITH THE PLATE, THE SCREW CAN FAIL. IT IS IMPORTANT, FROM THE CLINICAL POINT OF VIEW, THAT THE SCREW CAN BE REMOVED WITH THE APPROPRIATE INSTRUMENTS, THAT THE LENGTHENING OF OPERATIVE TIME IS NOT DRAMATIC, AND THAT THE PATIENT'S BONE IS NOT SERIOUSLY DAMAGED. ACCORDING TO REPORT, NONE OF THE MORE SERIOUS EVENTS TOOK PLACE. THE ROOT CAUSE FOR THIS FAILURE CANNOT BE IDENTIFIED WITH CERTAINTY. NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE PREVIOUS REPORTS. ON (B)(6) 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON 16 FEBRUARY 2016, THE (B)(4) ANALYZED THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: DURING THE VISUAL INVESTIGATION IT WAS OBSERVED THAT ALL THE PRONGS WERE BROKEN IN THE SAME MANNER: FULL DEFORMATION PRIOR TO FINAL BREAKAGE. ADDITIONALLY, IT WAS OBSERVED THAT THE PROXIMAL PART OF THE THREAD WAS PARTIALLY DAMAGED, PROBABLY DUE TO AN IMPINGEMENT WITH THE SCREW PLACED ON OPPOSITE SIDE. THIS MAKE US SUPPOSE THAT THE ENTERING POINT WAS TO OFF-CENTER AND THAT THE SCREW TRAJECTORY IN THE MEDIAL PLANE WAS EXCESSIVE. IT COULD BE THE REASON WHY IT WAS NOT POSSIBLE TO FULLY ADVANCE THE SCREW IN THE PLATE HOLE.

    Description of Event or Problem · 1

    WE HAD A CERVICAL PROCEDURE ON 3 LEVELS (C4-C5-C6-C7). WE USED 3 MECTA C CAGES WITH A MECTA C PLATE OF 58 MM AND 4 FIXED ANGLE SELF DRILLING AND 4 VARIABLE SELF DRILLING SCREWS. EVERYTHING WENT VERY GOOD EXCEPT THE LAST SCREW ON THE RIGHT SIDE OF THE PATIENT ON C4. THE PATIENT HAD A GOOD BONE QUALITY AND THE LAST SCREW HAD VERY, VERY GOOD GRIP, AS ALL THE OTHER SCREWS. THE LAST COUPLE OF TURNING THE SCREWHEAD BROKE IN 4 PIECES WHEN THE SURGEON TRIED TO ENGAGE THE SCREW FLUSH INTO THE PLATE. WE REMOVED THE CENTRAL SCREW, BECAUSE THE SCREWDRIVER AND SCREWDRIVER REMOVAL DIDN'T FIT ANYMORE INTO THE SCREW BECAUSE ALL THE CONNECTION POINT WHERE BROKEN. WE USED THE LOCKING SCREW EXTRACTOR (CODE 03.70.10.0022) INTO THE CENTRAL PART OF THE BONE SCREW AND WE WERE ABLE TO REMOVE WITHOUT ANY FURTHER TROUBLE THE BROKEN SCREW. WE USED A NEW VARIABLE SELF DRILLING SCREW AND THIS WITHOUT ANY PROBLEM. WE COULD FINISHED THE OPERATION WITH VERY GOOD RESULT. SURGERY DELAY WAS ABOUT 5 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27754 MECTA-C CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X) BONE SCREW FOR CERVICAL PLATES KWQ MEDACTA INTERNATIONAL SA 141365

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other