BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERAL LUMBAR TI-LIFE CAGE

    MDR report key: 19612925 · Received June 26, 2024

    Report

    Report Number
    3007728266-2024-00009
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    June 13, 2022
    Report Date
    July 2, 2024
    Manufacturer
    SPINEART SA
    Product Code
    OVD
    UDI-DI
    07640178987166
    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. THE FIRST EVENT REPORTS AN INTERVENTION TO STABILIZE THE LUMBOSACRAL JUNCTION WITH ARTHRODESIS L4-L5-S1. L5 WAS FRACTURED DUE TO OSTEOPOROSIS. THIS EVENT IS CLEARLY LINKED TO A SEVERELY DAMAGED BONE STRUCTURES THAT COULD PREVENT STABLE IMPLANTATION OF THE CAGE. THIS CONTRAINDICATION IS CLEARLY MENTIONED IN THE IFU. THIS EVENT IS PATIENT RELATED. THE SECOND EVENT REPORTS AN INCISIONAL HERNIA. SCIENTIFIC LITERATURE REPORTS THAT VENTRAL HERNIA IS COMMON COMPLICATION OF ABDOMINAL SURGERIES ((B)(4)). PLUS, THIS SIDE EFFECT IS CLEARLY IDENTIFIED IN THE CLINICAL EVALUATION REPORT (B)(4). BASED ON THE ABOVE INFORMATION, WE CONCLUDE THAT THE ISSUE REPORTED IS NOT LINKED TO THE DEVICE IMPLANTED BUT THAT IT IS RELATED TO THE PROCEDURE. THE THIRD EVENT REPORTS AN OCCLUSION (BOWEL OBSTRUCTION). AS PER THE INVESTIGATOR, THIS EVENT IS PROBABLY DUE TO THE PREVIOUS SURGERY (WALL SURGERY). BASED ON THE ABOVE INFORMATION, WE CONCLUDE THAT THE ISSUE REPORTED IS NOT LINKED TO THE DEVICE IMPLANTED BUT THAT IT IS RELATED TO THE PROCEDURE. BASED ON THE ABOVE INFORMATION, THE FIRST EVENT REPORTED IS DUE TO THE PATIENT CONDITION, THE SECOND AND THE THIRD EVENT REPORTED ARE DIRECTLY LINKED TO THE PROCEDURE. WE CLOSE THE CASE AS IS WITH NO FURTHER ACTION.

    Description of Event or Problem · 0

    WE RECEIVED A COMPLAINT FROM FRANCE ON 04.JUN.2024 REPORTING 3 AVERSE EVENTS. THE PATIENT UNDERWENT A SURGERY ON (B)(6) 2022 (CAGE IMPLANTATION). FIRST ADVERSE EVENT REPORTED: EVENT START DATE: (B)(6) 2022. EVENT DESCRIPTION: INTERVENTION TO STABILIZE THE LUMBOSACRAL JUNCTION WITH ARTHRODESIS L4L5S1. L5 FRACTURED DUE TO OSTEOPOROSIS. CAGE ARE NOT REMOVED. EVENT STOP DATE: (B)(6) 2022. SECOND ADVERSE EVENT REPORTED: EVENT START DATE: (B)(6) 2022. EVENT DESCRIPTION: FLANK LATERAL INCISIONAL HERNIA: REPAIR BY ABDOMINAL WALL HERNIORRHAPHY (NO IMPLANT). ACTION TAKEN: REINTERVENTION ON (B)(6) 2022. EVENT STOP DATE: (B)(6) 2022. THIRD ADVERSE EVENT REPORTED: EVENT START DATE: NOT REPORTED. EVENT DESCRIPTION: UNDERGOING DIGESTIVE SURGERY FOR AN OCCLUSION OF THE GRAFTED INTESTINE, POSSIBLY DUE TO A FLANGE OR ADHESION FOLLOWING THE WALL SURGERY HE UNDERWENT A FEW MONTHS EARLIER. ACTION TAKEN: SURGERY, DATE UNKNOWN EVENT STOP DATE: NOT REPORTED.

    Description of Event or Problem · 0

    WE RECEIVED A COMPLAINT FROM FRANCE ON 04.JUN.2024 REPORTING 3 AVERSE EVENTS. THE PATIENT UNDERWENT A SURGERY ON (B)(6) 2022 (CAGE IMPLANTATION). FIRST ADVERSE EVENT REPORTED: EVENT START DATE: (B)(6) 2022. EVENT DESCRIPTION: INTERVENTION TO STABILIZE THE LUMBOSACRAL JUNCTION WITH ARTHRODESIS L4L5S1. L5 FACTURED DUE TO OSTEOPOROSIS. CAGE ARE NOT REMOVED. EVENT STOP DATE: (B)(6) 2022. SECOND ADVERSE EVENT REPORTED: EVENT START DATE: (B)(6) 2022. EVENT DESCRIPTION: FLANK LATERAL INCISIONAL HERNIA: REPAIR BY ABDOMINAL WALL HERNIORRHAPHY (NO IMPLANT). ACTION TAKEN: REINTERVENTION ON (B)(6) 2022. EVENT STOP DATE: (B)(6) 2022. THIRD ADVERSE EVENT REPORTED: EVENT START DATE: NOT REPORTED. EVENT DESCRIPTION: UNDERGOING DIGESTIVE SURGERY FOR AN OCCLUSION OF THE GRAFTED INTESTINE, POSSIBLY DUE TO A FLANGE OR ADHESION FOLLOWING THE WALL SURGERY HE UNDERWENT A FEW MONTHS EARLIER. ACTION TAKEN: SURGERY, DATE UNKNOWN.EVENT STOP DATE: NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595869 LATERAL LUMBAR TI-LIFE CAGE LATERAL LUMBAR TI-LIFE CAGE OVD SPINEART SA JLT-MX 60 16-S 5-7935 07640178987166

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention