BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JULIET TI LL LATERAL LUMBAR TI-LIFE CAGE

    MDR report key: 20342187 · Received October 1, 2024

    Report

    Report Number
    3007728266-2024-00012
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    April 17, 2024
    Report Date
    October 14, 2024
    Manufacturer
    SPINEART SA
    Product Code
    MAX
    PMA / PMN Number
    K173702
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER WE RECEIVED THE COMPLAINT, THE MANUFACTURING FOLDERS HAVE BEEN REVIEWED. THE ANALYSIS ON THE MANUFACTURING DOCUMENTS AND CONTROL QUALITY DOCUMENTS DETECTED THAT RAW MATERIALS AND PRODUCTION PROCESSES WERE CONFORMING TO THE SPECIFICATIONS. WE DID NOT RECEIVE ANY POSTOPERATIVE PICTURE SHOWING THE ISSUES REPORTED. WE RECEIVED ON 23.SEP.2024 THE DRAFT NARRATIVE CASE "(B)(4)" WHICH EXPLAINS THAT: -PSEUDOARTHROSIS WAS DISCOVERED AT THE POSTERIOR FIXATION (L5/S1) ON THE 12-MONTH VISIT RADIOLOGICAL IMAGE ((B)(6) 2024). IT IS NOT AN ADJACENT SEGMENT DISEASE. A ALIF REINTERVENTION SURGERY WAS SCHEDULED ON (B)(6) 2024 AND THE STOP DATE OF THIS EVENT WAS ON (B)(6) 2024. PSEUDOARTHROSIS IS A SIDE EFFECT LISTED IN THE IFU. NEURAL COMPRESSION WAS DISCOVERED ON (B)(6) 2024, CAUSED BY FORAMINAL STENOSIS AT LEVEL L5/S1, PROBABLY CAUSED BY THE REINTERVENTION SURGERY REALIZED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT UNDERWENT ANOTHER REINTERVENTION SURGERY FOR A NEURAL DECOMPRESSION. NO MATERIAL WAS REMOVED DURING THIS REINTERVENTION AND THE STOP DATE OF THIS EVENT WAS ON (B)(6) 2024. NEURAL COMPRESSION (FORAMINAL STENOSIS) REPORTED IS AN ADJACENT SEGMENT DISEASE (L5/S1). ADJACENT SEGMENT DISEASE (ASD) IS A SIDE EFFECT CLINICALLY WELL-KNOWN. AS PER SCIENTIFIC LITERATURE, ADJACENT-SEGMENT DISEASE (ASD) IS A RELATIVELY COMMON SIDE EFFECT FOR ALIF, LLIF AND PLIF SURGERIES. BASED ON THE ABOVE INFORMATION, THE EVENTS REPORTED ARE DUE TO THE PROCEDURE: PSEUDOARTHROSIS IS AN EXPECTED UNDESIRABLE SIDE EFFECT LISTED IN THE IFU. NEURAL COMPRESSION IS A SIDE EFFECT (ADJACENT SEGMENT DISEASE) NOT LISTED IN THE IFU, BUT IT IS CLINICALLY WELL KNOWN. IT IS, FOR THE MOMENT, CONSIDERED AS AN UNEXPECTED UNDESIRABLE SIDE EFFECT AND IT WILL BE PART OF THE IFU AS PER CAPA-1326. SINCE THE LAUNCH OF THE PRODUCT, 7353 CAGES HAVE BEEN IMPLANTED AND THIS IS THE SECOND COMPLAINT WE RECEIVE REPORTING THIS KIND OF ISSUE, WHICH REPRESENTS A DEFECTIVE RATE OF (B)(4). THE RATE IS VERY LOW.

    Additional Manufacturer Narrative · 0

    AFTER WE RECEIVED THE COMPLAINT, THE MANUFACTURING FOLDERS HAVE BEEN REVIEWED. THE ANALYSIS ON THE MANUFACTURING DOCUMENTS AND CONTROL QUALITY DOCUMENTS DETECTED THAT RAW MATERIALS AND PRODUCTION PROCESSES WERE CONFORMING TO THE SPECIFICATIONS. WE DID NOT RECEIVE ANY POSTOPERATIVE PICTURE SHOWING THE ISSUES REPORTED. PSEUDOARTHROSIS AND NEURAL COMPRESSION (FORAMINAL STENOSIS) REPORTED ARE ADJACENT SEGMENT DISEASES (L5/S1). ADJACENT SEGMENT DISEASE (ASD) IS A SIDE EFFECT CLINICALLY WELL-KNOWN. AS PER SCIENTIFIC LITERATURE, ADJACENT-SEGMENT DISEASE (ASD) IS A RELATIVELY COMMON SIDE EFFECT FOR ALIF, LLIF AND PLIF SURGERIES. WE ARE WAITING FOR CLARIFICATION REGARDING THE SERIOUS ADVERSE EVENT PSEUDOARTHROSIS BECAUSE WE SUSPECT IT HAPPENED AT THE SURGERY LEVEL.

    Description of Event or Problem · 0

    ON 03.SEP.2024, WE RECEIVED A COMPLAINT FROM THE FIELD, FROM FRANCE, REPORTING THAT, AFTER A JULIET TI LL SURGERY REALIZED ON (B)(6) 2023, THE PATIENT FACED TWO SERIOUS ADVERSE EVENTS: SAE1: PSEUDOARTHROSIS START DATE: (B)(6) 2024. SAE2: NEURAL COMPRESSION (FORAMINAL STENOSIS) START DATE: (B)(6) 2024. ACCORDING TO THE PI, THESE EVENTS ARE NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. HOWEVER, ADJACENT LEVEL DISEASE IS A KNOWN RISK ON LUMBAR ARTHRODESIS, THEREFORE THE SPONSOR CANNOT EXCLUDE A RELATIONSHIP TO THE DEVICE OR THE PROCEDURE. ACTION TAKEN: 2 REINTERVENTIONS: REINTERVENTION 1 FOR THE PSEUDOARTHROSIS ON (B)(6) 2024, L5/S1 ALIF. REINTERVENTION 2 FOR THE STENOSIS ON (B)(6) 2024 FOR A DECOMPRESSION. SAE STOP DATES ARE THE SAME AS REINTERVENTION DATES.

    Description of Event or Problem · 0

    ON 03.SEP.2024, WE RECEIVED A COMPLAINT FROM THE FIELD (SEE (B)(4) FOLDER), FROM FRANCE, REPORTING THAT, AFTER A JULIET TI LL SURGERY REALIZED ON (B)(6) 2023, THE PATIENT FACED TWO SERIOUS ADVERSE EVENTS: SAE1: PSEUDOARTHROSIS START DATE: (B)(6) 2024. SAE2: NEURAL COMPRESSION (FORAMINAL STENOSIS) START DATE: (B)(6) 2024. ACCORDING TO THE PI, THESE EVENTS ARE NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. HOWEVER, ADJACENT LEVEL DISEASE IS A KNOWN RISK ON LUMBAR ARTHRODESIS, THEREFORE THE SPONSOR CANNOT EXCLUDE A RELATIONSHIP TO THE DEVICE OR THE PROCEDURE. ACTION TAKEN: 2 REINTERVENTIONS - REINTERVENTION 1 FOR THE PSEUDOARTHROSIS ON (B)(6) 2024, L5/S1 ALIF. - REINTERVENTION 2 FOR THE STENOSIS ON (B)(6) 2024 FOR A DECOMPRESSION. SAE STOP DATES ARE THE SAME AS REINTERVENTION DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45598 JULIET TI LL LATERAL LUMBAR TI-LIFE CAGE JULIET TI LL LATERAL LUMBAR TI-LIFE CAGE MAX SPINEART SA JLT-S8 40 10-S AND JLT-S8 40 12-S 7-0773 AND 5-1758

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention