BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINAL TIGHTENER PERLA TL

    MDR report key: 18986110 · Received March 27, 2024

    Report

    Report Number
    3007728266-2024-00003
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    March 20, 2024
    Report Date
    June 20, 2024
    Manufacturer
    SPINEART SA
    Product Code
    HXX
    UDI-DI
    07640450868954
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER WE RECEIVED THE COMPLAINT, THE MANUFACTURING FOLDER HAS BEEN REVIEWED. THE ANALYSIS OF THE MANUFACTURING DOCUMENTS AND CONTROL QUALITY DOCUMENTS DETECTED THAT RAW MATERIALS AND PRODUCTION PROCESSES WERE CONFORMING TO THE SPECIFICATIONS. COMPLAINED INSTRUMENT BELONGS TO A BATCH 55 UNITS, MANUFACTURED ON MARCH 2023 AND THIS IS THE SECOND COMPLAINT WE RECEIVE FOR THIS TYPE OF DEFECT AND FOR THIS BATCH. WE RECEIVED 2 OTHER COMPLAINTS REPORTING THE SAME KIND OF ISSUE FOR 2 OTHERS BATCHES. WE RECEIVED THE INVOLVED INSTRUMENT, AND WE OBSERVED BROWN MATERIAL ON THE INSTRUMENT. WE INFORMED OUR SUBCONTRACTOR, AND WE OPENED THE INTERNAL NON-CONFORMITY NC-2164 FOR DEEPER INVESTIGATION. BASED ON THE CONCLUSION OF THE PREVIOUS INVESTIGATION (SEE NC-2164) A DESIGN IMPROVEMENT HAS BEEN DECIDED VIA PCR79-26-00.

    Additional Manufacturer Narrative · 0

    WE ARE WAITING FOR THE RETURN OF THE INSTRUMENT TO INVESTIGATE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, WE RECEIVED A COMPLAINT FROM SPAIN, REGISTERED UNDER CPT-2883, REPORTING THAT DURING A SURGERY ON (B)(6) 2024, WHEN USING THE FINAL TIGHTENER INSTRUMENT REFERENCE TLF-IN 05 41-N, BATCH NUMBER 6-9649/051, BROWN WATER LEAKED INTO THE SURGICAL SITE.HIGH RISK OF INFECTION REPORTED.THE EVENT IS REPORTED TO FDA BECAUSE THIS INSTRUMENT IS USED IN THE US MARKET. THE PATIENT RECEIVED ANTIBIOTIC TREATMENT TO PREVENT ANY POTENTIAL INFECTION. NO FURTHER COMPLICATIONS.

    Description of Event or Problem · 0

    ON 21.MAR.2024, WE RECEIVED A COMPLAINT FROM SPAIN, REGISTERED UNDER (B)(4) REPORTING THAT DURING A SURGERY ON (B)(6) 2024, WHEN USING THE FINAL TIGHTENER INSTRUMENT REFERENCE TLF-IN 05 41-N, BATCH NUMBER 6-9649/051, BROWN WATER LEAKED INTO THE SURGICAL SITE. HIGH RISK OF INFECTION REPORTED. THE EVENT IS REPORTED TO FDA BECAUSE THIS INSTRUMENT IS USED IN THE US MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494362 FINAL TIGHTENER PERLA TL FINAL TIGHTENER PERLA TL HXX SPINEART SA TLF-IN 05 41-N 6-9649 07640450868954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other