BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTAB CANNULATED FENESTRATED POLYAXIAL SCREW

    MDR report key: 20093607 · Received August 29, 2024

    Report

    Report Number
    3007728266-2024-00011
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 1, 2024
    Report Date
    October 25, 2024
    Manufacturer
    SPINEART SA
    Product Code
    NKB
    PMA / PMN Number
    K203506
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED THE BROKEN SCREWS ON 22.AUG.2024. THE INVESTIGATION IS CURRENTLY ONGOING TO DETERMINE THE ROOT CAUSE OF THE ISSUE. DHR IS CONFORMING TO THE SPECIFICATION.

    Additional Manufacturer Narrative · 0

    AFTER RECEPTION OF THE COMPLAINT, THE DEVICE HISTORY RECORD HAS BEEN REVIEWED. THE MANUFACTURING PROCESS AND THE QUALITY CONTROL DOCUMENTS WERE ANALYZED. IT IS CONFIRMED THAT BOTH SCREWS WERE MANUFACTURED ACCORDING TO THE PREDEFINED SPECIFICATIONS AND THAT THERE WERE NO NON-CONFORMITIES OBSERVED DURING THE PRODUCTION PROCESS. THERE HAVE BEEN IN TOTAL 40 UNITS OF BATCH 7-9957 AND (B)(4) UNITS OF BATCH 8-0175 PRODUCED, FROM WHICH 4 UNITS FOR THE FIRST BATCH NUMBER AND (B)(4) UNITS FOR THE SECOND BATCH NUMBER ALREADY HAVE BEEN IMPLANTED. THIS IS THE FIRST COMPLAINT WE RECEIVED FOR EACH OF THESE TWO BATCHES. WE RECEIVED THE SCREWS, AND WE CAN CLEARLY SEE THAT THESE BROKE AT THE HOLES AFTER RECEPTION OF THE COMPLAINT, THE DEVICE HISTORY RECORD HAS BEEN REVIEWED. THE MANUFACTURING PROCESS AND THE QUALITY CONTROL DOCUMENTS WERE ANALYZED. IT IS CONFIRMED THAT BOTH SCREWS WERE MANUFACTURED ACCORDING TO THE PREDEFINED SPECIFICATIONS AND THAT THERE WERE NO NON-CONFORMITIES OBSERVED DURING THE PRODUCTION PROCESS. THERE HAVE BEEN IN TOTAL 40 UNITS OF BATCH 7-9957 AND (B)(4) UNITS OF BATCH 8-0175 PRODUCED, FROM WHICH 4 UNITS FOR THE FIRST BATCH NUMBER AND 14 UNITS FOR THE SECOND BATCH NUMBER ALREADY HAVE BEEN IMPLANTED. THIS IS THE FIRST COMPLAINT WE RECEIVED FOR EACH OF THESE TWO BATCHES. WE RECEIVED THE SCREWS, AND WE CAN CLEARLY SEE THAT THESE BROKE AT THE HOLES. A MEETING WAS HOLD ON (B)(6) 2024 TO DISCUSS THE ACTIONS TO TAKE, AND A SECOND MEETING WAS HOLD ON 23 AUG 2024. AFTERWARDS, THE FOLLOWING CONTROLS WERE PERFORMED: - 1 NEW UNIT OF THE BATCH 7-9957 AND 1 NEW UNIT OF BATCH 8-0175 WERE TAKEN OUT OF THE STOCK AND CONTROLLED FOR THE FOLLOWING PROPERTIES: · DIAMETER OF THREAD ROOT/SHAPE OF THREAD · CANNULA DIAMETER · PERFORATION DIAMETER · INTERNAL APPEARANCE OF THE CANNULA · PERFORATION POSITIONS HESE TWO UNITS ARE FOUND TO BE CONFORM TO THE SPECIFICATIONS. NO DEVIATION OBSERVED. - THE R&D CONDUCTED FUNCTIONALITY TESTS ON SCREWS FROM THE SAME RANGE, BY INSERTING THREE DIFFERENT SCREWS WITH A DIAMETER 5.5 AND LENGTHS OF 40 OR 45 IN PCF30/15 (BONE REALISTIC), PCF30 (HARD BONE) AND PCF40 (VERY HARD BONE). FROM THESE TESTS, IT IS OBSERVED THAT IT SEEMS THAT THE FRACTURE OCCURS AT THE START OF THE SCREWING PROCESS IN VERY HARD BONE. THIS BREAKAGE CAN BE COMBINED WITH THE BENDING FORCES APPLIED WHEN SCREWING: THIS MAY EXPLAIN WHY LONGER SCREWS ARE MORE PRONE TO BREAKAGE. A PRE-TAPPED SCREW LIMITS THE TORQUE SIGNIFICANTLY AND ALLOWED TO REACH 7-8NM AT THE END OF THE SCREW WITHOUT BREAKING. - THE COMPLAINED SCREWS WERE SENT TO THE EXAMINATION LABORATORY CRITT IN ORDER TO DO AN INSPECTION OF THE BREAKAGE SITE, BUT WE DID NOT YET RECEIVE THE REPORT. THE ROOT CAUSE OF THIS COMPLAINT AND THE ACTIONS TO IMPLEMENT WILL BE INVESTIGATED BY CAPA-1347.

    Description of Event or Problem · 0

    DURING A SURGERY ON (B)(6) 2024, 2 SCREWS BROKE DURING INSERTION IN THE AREA OF THE FENESTRATION HOLE WHEN THE SCREWS PASSED THROUGH THE PEDICLE. THIS HAPPENED ON L4 (RIGHT SIDE) AND L5 (LEFT SIDE). BOTH SIDER WERE TAPPED WITH A 5MM TAP. BROKEN TIPS WERE RETRIEVED. THE SURGEON COMPLETED THE SURGERY WITH OTHER SCREWS. THE PATIENT RECEIVED ADDITIONAL ANAESTHESIA. THE SURGERY DELAY WAS APPROXIMATELY 90 MINUTES MORE. THE PATIENT IS FINE.

    Description of Event or Problem · 0

    DURING A SURGERY ON (B)(6) 2024, 2 SCREWS BROKE DURING INSERTION IN THE AREA OF THE FENESTRATION HOLE WHEN THE SCREWS PASSED THROUGH THE PEDICLE. THIS HAPPENED ON L4 (RIGHT SIDE) AND L5 (LEFT SIDE). BOTH SIDES WERE TAPPED WITH A 5MM TAP. BROKEN TIPS WERE RETRIEVED. THE SURGEON COMPLETED THE SURGERY WITH OTHER SCREWS. THE PATIENT RECEIVED ADDITIONAL ANAESTHESIA. THE SURGERY DELAY WAS APPROXIMATELY 90 MINUTES MORE. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269380 XTAB CANNULATED FENESTRATED POLYAXIAL SCREW XTAB CANNULATED FENESTRATED POLYAXIAL SCREW NKB SPINEART SA MPF-PX 55 50-S 7-9957 AND 8-0175

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown