BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERLA TL POLYAXIAL SCREW

    MDR report key: 20554524 · Received October 29, 2024

    Report

    Report Number
    3007728266-2024-00015
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    September 10, 2024
    Report Date
    November 29, 2024
    Manufacturer
    SPINEART SA
    Product Code
    NKB
    PMA / PMN Number
    K193396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOR THE MOMENT, WE ONLY HAVE BEEN INFORMED ABOUT THE EVENT, BUT THE DEVICES HAVE NOT YET BEEN RETURNED. THE COMPLAINED DEVICES ARE THE FOLLOWING: TLF-PS 75 55-S, 5-8622, TLF-PS 75 55-S, 5-8624, TLF-SC 00 00-S, 7-7520, TLF-SC 00 00-S, 7-0670, TLF-SC 00 00-S, 7-7613, TLF-SC 00 00-S, 5-8617, TLF-SC 00 00-S, 7-6090, TLF-SC 00 00-S, 5-8679, TLF-SC 00 00-S, 5-8625, TLF-SC 02 00-S, 7-6729, TLF-SC 00 00-S, 7-3638, TLF-SC 00 00-S, 6-8134. IT IS THE FIRST COMPLAINT WE RECEIVED FOR EACH BATCH. WE ARE AWAITING THE RETURN OF THE DEVICE TO CONTINUE THE INVESTIGATION PROCESS.

    Additional Manufacturer Narrative · 0

    FOR THE MOMENT, WE ONLY HAVE BEEN INFORMED ABOUT THE EVENT, BUT THE DEVICES HAVE NOT YET BEEN RETURNED. THE COMPLAINED DEVICES ARE THE FOLLOWING: TLF-PS 75 55-S, 5-8622, TLF-PS 75 55-S, 5-8624, TLF-SC 00 00-S, 7-7520, TLF-SC 00 00-S, 7-0670, TLF-SC 00 00-S, 7-7613, TLF-SC 00 00-S, 5-8617, TLF-SC 00 00-S, 7-6090, TLF-SC 00 00-S, 5-8679, TLF-SC 00 00-S, 5-8625, TLF-SC 02 00-S, 7-6729, TLF-SC 00 00-S, 7-3638, TLF-SC 00 00-S, 6-8134. IT IS THE FIRST COMPLAINT WE RECEIVED FOR EACH BATCH. THE INVESTIGATION WAS STARTED BY REVIEWING THE MANUFACTURING FOLDER OF EACH DEVICE LISTED IN THE TABLE HEREABOVE. WE CONCLUDED THAT THE PRODUCTION PROCESS AND THE QUALITY CONTROL OF THESE DEVICES WERE CONFORM TO THE PREDEFINED SPECIFICATIONS. THERE WERE NO NON-CONFORMITIES OBSERVED. HISTORICAL ANALYSIS SHOWS THAT THIS IS THE FIRST COMPLAINT THAT WE RECEIVED FOR THE SPECIFIC BATCH OF EACH REFERENCE, EXCEPT FOR BATCH NUMBER 5-7419. CURRENT CASE IS THE 3RD COMPLAINT, WHICH IS RECEIVED FOR THIS BATCH, BUT THE 2ND FOR BREAKING ISSUES. WE RECEIVED FOLLOWING IMAGES (POST-OPERATIVE IMAGES, TAKEN ON (B)(6) 2024). THE DEVICES WERE RETURNED, AND THEY WERE INSPECTED BY THE R&D TEAM: 1. SETSCREWS TLF-SC 00 00-S AND TLF-SC 02 00-S. THERE WERE NO DEFECTS OBSERVED. 2. MULTIAXIAL CROSS CONNECTOR PREBENT TLF-CC MP 55-S. ONE OF THE HOOKS OF THE CROSS CONNECTOR IS BROKEN. SPINEART ALREADY RECEIVED SIMILAR COMPLAINTS REGARDING THIS DEFECT. PREVIOUSLY, THE R&D TEAM TRIED TO REPRODUCE THE BREAKAGE ON SIMILAR DEVICES IN NORMAL USE, AND THE DEFECT COULD NOT BE REPRODUCED. THE BREAKAGE HAS ONLY BEEN OBSERVED IN CRITICAL CONFIGURATIONS (HIGHER TORQUE COMBINED WITH NON-AXIAL TIGHTENING). SINCE 2020, (B)(4) CROSS CONNECTORS HAVE BEEN IMPLANTED AND 11 RETURNS FROM THE FIELD HAVE BEEN REGISTERED. IT REPRESENTS (B)(4) OF THE ISSUE. DESPITE THE LOW RATE OF ISSUE AND DESPITE THE BREAKAGE COULD NOT BE REPRODUCED, IT WAS PREVIOUSLY DECIDED TO IMPROVE THE DESIGN VIA PCR79-18-00. AS AN IMPROVEMENT, A RADIUS IS MENTIONED AT THE BOTTOM OF THE BORE OF THE THREAD. THE BATCH INVOLVED IN THIS COMPLAINT WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF THE PCR79-18-00. WE DID NOT RECEIVE ANY COMPLAINT FOR BREAKAGE AFTER THE IMPLEMENTATION OF THIS ACTION. 3. POLYAXIAL SCREWS TLF-PS 75 55-S. THE POLYAXIAL SCREW WITH BATCH NUMBER 5-6622 IS DISASSEMBLED, WHILE THE ONE WITH BATCH NUMBER 5-8624 IS STILL ASSEMBLED. THE SETSCREW, BATCH NUMBER 7-7520 IS STILL CONNECTED TO THE HEAD OF THE POLYAXIAL SCREW, BUT IN A TRANSVERSAL WAY. THERE ARE DIFFERENT USURE MARKS NOTICED ON THE SCREW HEAD, WHICH SHOWS INTENSE MANIPULATION. PREVIOUSLY, RETURNS FROM THE FIELD DESCRIBED EASILY DETECTABLE DISASSEMBLY DURING THE SCREWING STEP OF THE SURGERY. INVESTIGATION WAS DONE BY THE R&D TEAM, AND THIS DISLOCATION HAS BEEN REPRODUCED, BUT IN EXTREME CONDITION. AFTER RETURNS FOR THIS KIND OF ISSUE, IT WAS DECIDED TO OPEN PCR79-13-00 TO OPTIMIZE THE ALIGNMENT OF THE CLIP WITH THE SCREWHEAD TO AVOID THIS MISALIGNMENT AND OPTIMIZE THE CONNECTION WITH THE BONE SCREW. THIS ACTION WAS APPLIED AFTER (B)(6) 2022, WHILE THE SCREW WITH BATCH NUMBER 5-6622 HAS BEEN PRODUCED IN 2021. SINCE THE IMPLEMENTATION OF THE PCR79-13-00, WE HAVE NOT RECEIVED ANY RETURN REPORTING DISASSEMBLING POST-OPERATIVELY. WE DECIDED TO INFORM THE FDA OF THIS CASE VIA (B)(4) AS THE DEVICE CONTRIBUTED TO A SERIOUS INJURY (REVISION SURGERY). THE ROOT CAUSE OF THIS COMPLAINT, REGARDING THE BROKEN HOOK AND THE DISSEMBLED SCREW, IS PRODUCT RELATED. THERE IS NO DEFECT DETECTED FOR THE SET SCREWS. THIS IS AN ISOLATED CASE, BUT WE REMAIN EXTREMELY VIGILANT TO THIS KIND OF ISSUE AND WE KEEP MONITORING.

    Description of Event or Problem · 0

    ON 03 OCTOBER 2024, WE RECEIVED THE COMPLAINT: (B)(4) FROM THE US, REPORTING THAT FOLLOWING A FIRST SURGERY ON (B)(6) 2024, THE PATIENT RETURNED FOR AN OFFICE VISIT DUE TO PAIN. UPON TAKING X-RAYS, THE SURGEON NOTICED THE IMPLANT FAILURE. SCREWS FRACTURE AND SET SCREWS POPPED OFF.

    Description of Event or Problem · 0

    ON (B)(6) 2024, WE RECEIVED THE COMPLAINT (B)(4) FROM THE US, REPORTING THAT FOLLOWING A FIRST SURGERY ON (B)(6) 2024, THE PATIENT RETURNED FOR AN OFFICE VISIT DUE TO PAIN. UPON TAKING X-RAYS, THE SURGEON NOTICED THE IMPLANT FAILURE. SCREWS FRACTURE AND SET SCREWS POPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916192 PERLA TL POLYAXIAL SCREW PERLA TL POLYAXIAL SCREW NKB SPINEART SA TLF-PS 75 55-S

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention