BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCARLET ALT SECURED LUMBAR ANTERIOR CAGE

    MDR report key: 19474548 · Received June 6, 2024

    Report

    Report Number
    3007728266-2024-00005
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    January 9, 2024
    Report Date
    June 6, 2024
    Manufacturer
    SPINEART SA
    Product Code
    OVD
    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. COMPLAINED DEVICES BELONG TO TWO DIFFERENT BATCHES; FOR BATCH NUMBER 5-0945, (B)(4) DEVICES HAVE BEEN MANUFACTURED AND (B)(4) DEVICES HAVE ALREADY BEEN IMPLANTED WITH NO RETURN FROM THE FIELD, FOR BATCH NUMBER 6-0034, (B)(4) DEVICES HAVE BEEN MANUFACTURED AND (B)(4) DEVICES HAVE ALREADY BEEN IMPLANTED WITH RETURN FROM THE FIELD. THE ANALYSIS ON THE MANUFACTURING DOCUMENTS AND CONTROL QUALITY DOCUMENTS DETECTED THAT RAW MATERIALS AND PRODUCTION PROCESSES WERE CONFORMING TO THE SPECIFICATIONS. SPINEART WAS MADE AWARE OF THESE EVENTS ON 28.MAY.2024. WE WERE INFORMED ON 29.MAY.2024 THAT NO OPERATIVE PICTURE IS AVAILABLE. SCIENTIFIC LITERATURE REPORTS THAT VENTRAL HERNIA IS COMMON COMPLICATION OF ABDOMINAL SURGERIES (SEE "NHO" AND "CARO" ARTICLES - CPT FOLDER). PLUS, THE CAUSAL RELATIONSHIP OF THIS EVENT TO THE DEVICE, PROCEDURE, INSTRUMENT WAS CLASSIFIED AS NOT RELATED BY THE REPORTING INVESTIGATOR AS DUE TO A CONGENITAL MALFORMATION (SEE CASE NARRATIVE SIGNED BY THE SURGEON). 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 AND THE PATIENT CONDITION. SINCE THE LAUNCH OF THE DEVICE, 17891 CAGES HAVE BEEN IMPLANTED AND THIS IS THE FIFTH COMPLAINT WE RECEIVE FOR THIS KIND OF ISSUE, WHICH REPRESENTS 0,03% OF ISSUE, THE RATE IS VERY LOW. WE CLOSE THE CASE AS IS WITH NO FURTHER ACTION. THE CASE WAS REPORTED TO THE FRENCH NATIONAL COMPETENT AUTHORITY (ANSM) VIA (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2024, WE RECEIVED A COMPLAINT FROM THE FIELD FROM FRANCE (SEE CPT-2999 FOLDER) REPORTING THAT, THE PATIENT UNDERWENT A SPINE SURGERY (L5/S1 + L4/L5) ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT HAD A SMALL UMBILICAL HERNIA WHICH MADE HIM A LITTLE UNCOMFORTABLE (MILD SEVERITY). ACCORDING TO THE SITE, IT WAS DUE TO A CONGENITAL MALFORMATION (CONFIRMED ON THE DCF). THE EVENT BECAME SERIOUS AFTER AN ABDOMINAL EVENTRATION, FOR WHICH THE PATIENT WAS OPERATED ON (B)(6) 2024 (NO DEVICE EXPLANTATION). THE EVENT WAS SOLVED ON 09.JAN.2024 AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054404 SCARLET ALT SECURED LUMBAR ANTERIOR CAGE SCARLET ALT SECURED LUMBAR ANTERIOR CAGE OVD SPINEART SA SCA-LM 15 14-S AND SCA-LM 15 12-S 5-0945 AND 6-0034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention