BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINAL TIGHTENER PERLA TL

    MDR report key: 20586640 · Received November 1, 2024

    Report

    Report Number
    3007728266-2024-00016
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    October 10, 2024
    Report Date
    January 9, 2025
    Manufacturer
    SPINEART SA
    Product Code
    HXX
    UDI-DI
    07640450868954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THE COMPLAINT, THE MANUFACTURING FOLDER HAS BEEN REVIEWED. THE ANALYSIS OF THE MANUFACTURING DOCUMENTS AND CONTROL QUALITY DOCUMENTS DETECTED THAT THE RAW MATERIALS, PRODUCTION PROCESSES AND FINISHED PRODUCTS WERE CONFORMING TO THE SPECIFICATIONS. COMPLAINED INSTRUMENT BELONGS TO A BATCH (B)(4) UNITS, MANUFACTURED ON MARCH 2023 AND THIS IS THE FIRST COMPLAINT WE RECEIVE FOR THIS TYPE OF DEFECT FOR THIS BATCH. WE RECEIVED THE INVOLVED INSTRUMENT, AND IT WAS SENT TO OUR SUBCONTRACTOR FOR INVESTIGATION. CONSIDERING THE NATURE OF THE ISSUE REPORTED IN THIS COMPLAINT, IT WAS DECIDED TO ACTIVATE OUR INTERNAL CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) PROCESS AND THE CAPA-1354 HAS BEEN OPENED ACCORDINGLY. THE INVESTIGATION ON THE POSSIBLE ROOT CAUSES PERFORMED IN THE CONTEXT OF THIS CAPA, CONCLUDED THAT IN SOME VERY RARE CASES OF DIMENSIONAL VARIATIONS, SOME RESIDUES OF MOISTURE GENERATED DURING THE CLEANING AND/OR STERILIZATION PROCESS, MAY ENTER IN THE CAPSULE UNDERNEATH THE HANDLE. IT WAS THEREFORE DECIDED TO IMPROVE THE DESIGN OF THIS CAPSULE TO ENSURE A PERFECT TIGHTNESS DURING CLEANING AND STERILIZATION PROCESSES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    ON 10.OCT.2024, WE RECEIVED A COMPLAINT FROM FRANCE REGISTERED UNDER CPT-3260, REPORTING THAT DURING A SURGERY ON (B)(6) 2024, WHEN USING THE FINAL TIGHTENER INSTRUMENT REFERENCE TLF-IN 05 41-N, BATCH NUMBER 6-8534/001, WATER LEAKED INTO THE PATIENT. THE SURGEON COMPLETED THE SURGERY BY USING ANOTHER INSTRUMENT. THE SURGICAL SITE WAS WASHED WITH BETADINE SERUM (THE PATIENT IS UNDER SYSTEMATIC PREOPERATIVE ANTIBIOTIC TREATMENT). THE PATIENT IS FINE AND HE LEFT THE HOSPITAL WITH NO PROLONGED HOSPITALIZATION.

    Description of Event or Problem · 0

    ON 10.OCT.2024, WE RECEIVED A COMPLAINT FROM FRANCE REGISTERED UNDER CPT-3260, REPORTING THAT DURING A SURGERY ON (B)(6) 2024, WHEN USING THE FINAL TIGHTENER INSTRUMENT REFERENCE TLF-IN 05 41-N, BATCH NUMBER 6-8534/001, WATER LEAKED INTO THE PATIENT. THE SURGEON COMPLETED THE SURGERY BY USING ANOTHER INSTRUMENT. THE SURGICAL SITE WAS WASHED WITH BETADINE SERUM (THE PATIENT IS UNDER SYSTEMATIC PREOPERATIVE ANTIBIOTIC TREATMENT). THE PATIENT IS FINE AND HE LEFT THE HOSPITAL WITH NO PROLONGED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161375 FINAL TIGHTENER PERLA TL FINAL TIGHTENER PERLA TL HXX SPINEART SA TLF-IN 05 41-N 6-8534 07640450868954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female