BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERAL LUMBAR TI-LIFE CAGE

    MDR report key: 19728087 · Received July 12, 2024

    Report

    Report Number
    3007728266-2024-00010
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    December 1, 2023
    Report Date
    July 12, 2024
    Manufacturer
    SPINEART SA
    Product Code
    OVD
    UDI-DI
    07640178987074
    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 FOLDER HAS 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 RECEIVED A POSTOPERATIVE PICTURE SHOWING A DISCAL HERNIA AT ADJACENT SEGMENT L5/S1 (MRI ON (B)(6) 2024). ADJACENT SEGMENT DISEASE (ASD) IS A SIDE EFFECT CLINICALLY WELL-KNOWN. AS PER SCIENTIFIC LITERATURE, ADJACENT-SEGMENT DISEASE (ASD) IS A RELATIVELY COMMON INDICATION FOR FURTHER SURGICAL INTERVENTION AFTER LUMBAR SPINE SURGERY: - "ADJACENT-SEGMENT DISEASE (ASD) REQUIRING OPERATIVE INTERVENTION IS A RELATIVELY COMMON LONG-TERM CONSEQUENCE OF LUMBAR FUSION SURGERY" (INCIDENCE OF ADJACENT-SEGMENT SURGERY FOLLOWING STAND-ALONE LATERAL LUMBAR INTERBODY FUSION - JNS SPINE) - ADJACENT SEGMENT DEGENERATION AFTER SHORT-SEGMENT LATERAL LUMBAR INTERBODY FUSION (LLIF) - PMC (NIH.GOV) - NATIONAL LIBRARY OF MEDICINE - CHARACTERIZATION AND RATE OF SYMPTOMATIC ADJACENT-SEGMENT DISEASE AFTER INDEX LATERAL LUMBAR INTERBODY FUSION: A SINGLE-INSTITUTION, MULTISURGEON CASE SERIES WITH LONG-TERM FOLLOW-UP IN: JOURNAL OF NEUROSURGERY: SPINE VOLUME 35 ISSUE 2 (2021) JOURNALS (THEJNS.ORG) - JNS JOURNAL OF NEUROSURGERY BASED ON THE ABOVE INFORMATION, THE EVENT REPORTED IS DUE TO THE PROCEDURE. WE CLOSE THE CASE AS IS WITH NO FURTHER ACTION. BECAUSE OF RE-INTERVENTION SURGERY (NO EXPLANTATION) WE DECIDED TO INFORM (B)(6) VIA (B)(4) AND TO INFORM FDA VIA MDR-10-2024 BECAUSE THE DEVICE INVOLVED IS US MARKETED.

    Description of Event or Problem · 0

    ON 17.MAY.2024, WE RECEIVED A COMPLAINT FROM THE FIELD (SEE CPT-2996 FOLDER), FROM FRANCE, REPORTING THAT, AFTER A SURGERY REALIZED ON (B)(6) 2022, THE PATIENT STARTED TO HAVE PAIN WITH SLIGHT LAMENESS WHEN WALKING IN THE RIGHT LOWER LIMB, TRUNCATED IN THE THIGH, RATHER ON THE ANTERO-LATERAL SIDE, SINCE (B)(6) 2022. THE ACTION TAKEN AT THIS TIME WERE HIP X-RAY ASSESSMENT, MRI ASSESSMENT THEN CONSULTATION. ON 03.JUN.2024, WE RECEIVED ADDITIONAL INFORMATION. THE PATIENT STARTED TO HAVE PERSISTENT LUMBORADICULAR PAIN IN THE RIGHT LOWER LIMB, TYPICAL SCIATICA, INCREASINGLY INCAPACITATING MECHANICS SINCE 01.DEC.2023. A LUMBAR MRI AND INFILTRATION WERE REALIZED. A DISCAL HERNIA AT ADJACENT SEGMENT L5/S1 WAS DETECTED. THE PATIENT UNDERWENT A NEW INTERVENTION ON (B)(6) 2024 (LUMBAR DISCECTOMY, NO EXPLANTATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289644 LATERAL LUMBAR TI-LIFE CAGE LATERAL LUMBAR TI-LIFE CAGE OVD SPINEART SA JLT-MX 50 14-S 4-9573 07640178987074

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention