BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINAL TIGHTENER PERLA TL

    MDR report key: 20912060 · Received December 12, 2024

    Report

    Report Number
    3007728266-2024-00018
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    October 15, 2024
    Report Date
    February 12, 2025
    Manufacturer
    SPINEART SA
    Product Code
    HXX
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING. WE ARE WAITING FOR THE RETURN OF THE INSTRUMENTS TO INVESTIGATE.

    Additional Manufacturer Narrative · 0

    AFTER WE RECEIVED THE COMPLAINT, THE MANUFACTURING DOCUMENTS AND QUALITY CONTROL DOCUMENTS OF BOTH INSTRUMENTS WERE ANALYZED. IT IS OBSERVED THAT THE RAW MATERIALS AND PRODUCTION PROCESSES ARE CONFORM TO THE SPECIFICATIONS. THERE HAS BEEN NO DEVIATION OBSERVED DURING THE MANUFACTURING PROCESS. (B)(6): (B)(4) DEVICES OF THIS BATCH HAVE BEEN MANUFACTURED IN MAY 2024 AND THERE ARE 6 UNITS ON THE MARKET. THIS IS THE 3RD COMPLAINT WE RECEIVED FOR THIS BATCH, BUT THE 1ST FOR THIS TYPE OF ISSUE. (B)(6): (B)(4) DEVICES OF THIS BATCH HAVE BEEN MANUFACTURED IN JUN 2023 AND THERE ARE (B)(4) UNITS ON THE MARKET. THIS IS THE 1ST COMPLAINT WE RECEIVED FOR THIS BATCH. WE RECEIVED BOTH INSTRUMENTS, AND THE RD TEAM INSPECTED THEM: NO INSTRUMENT TIPS ARE STRIPPED THE R&D TEAM CONNECTED THE TIPS TO A SETSCREW AND TIGHTENED IT WITHOUT DIFFICULTY THE TORQUE TESTS ARE CONFORMING TO THE SPECIFICATION (12 NM +/- 1 NM): 11.763 NM (B)(6) AND 11.933 NM (B)(6). BOTH INSTRUMENTS ARE FUNCTIONAL, THERE IS NO TIGHTENING ISSUE. THE MAIN HYPOTHESIS TO EXPLAIN THE ISSUE REPORTED IS THAT THE SETSCREW WAS NOT TIGHTENED DURING THE SURGERY.

    Description of Event or Problem · 0

    ON (B)(6)2024, WE RECEIVED A COMPLAINT FROM FRANCE REGISTERED UNDER CPT-3361, REPORTING THAT DURING A L4/L5 SURGERY ON (B)(6) 2024, THE SURGEON DETECTED A TIGHTENING ISSUE AS THE IMPLANTED ROD WAS LOOSEN. THE SURGEON COULD NOT IDENTIFIED THE INVOLVED INSTRUMENT BECAUSE HE USED 2 INSTRUMENTS. THE SURGEON COMPLETED THE SURGERY SUCCESSFULLY WITH NO IMPACT ON THE PATIENT BUT THE SURGERY WAS DELAYED BY MORE THAN 30 MINUTES.

    Description of Event or Problem · 0

    ON (B)(6) 2024, WE RECEIVED A COMPLAINT FROM FRANCE REGISTERED UNDER CPT-3361, REPORTING THAT DURING A L4/L5 SURGERY ON (B)(6) 2024, THE SURGEON DETECTED A TIGHTENING ISSUE AS THE IMPLANTED ROD WAS LOOSEN. THE SURGEON COULD NOT IDENTIFIED THE INVOLVED INSTRUMENT BECAUSE HE USED 2 INSTRUMENTS. THE SURGEON COMPLETED THE SURGERY SUCCESSFULLY WITH NO IMPACT ON THE PATIENT BUT THE SURGERY WAS DELAYED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168529 FINAL TIGHTENER PERLA TL SCREWDRIVER HXX SPINEART SA TLF-IN 05 41-N A-0663/010 OR A-2575/25

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other