BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCARLET ALT SECURED LUMBAR ANTERIOR CAGE - HYPERLORDOTIC

    MDR report key: 21178699 · Received January 17, 2025

    Report

    Report Number
    3007728266-2025-00001
    Event Type
    Injury
    Date Received
    January 17, 2025
    Date of Event
    January 1, 2024
    Report Date
    January 17, 2025
    Manufacturer
    SPINEART SA
    Product Code
    OVD
    UDI-DI
    07640185342071
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEPTION OF THE COMPLAINT, THE MANUFACTURING FOLDER HAS BEEN REVIEWED. IT IS CONFIRMED THAT THE RAW MATERIALS AND PRODUCTION PROCESSES ARE CONFORM TO THE PREDEFINED SPECIFICATIONS. THERE HAVE BEEN NO NON-CONFORMITIES OBSERVED DURING THE MANUFACTURING PROCESS. COMPLAINED DEVICE BELONGS TO A BATCH OF (B)(4) UNITS, MANUFACTURED IN (B)(6) 2021. THIS IS THE 1ST COMPLAINT WE RECEIVED FOR THIS BATCH. SCIENTIFIC LITERATURE REPORTS THAT VENTRAL HERNIA (SIMILAR TO EVENTRATION) IS A COMMON COMPLICATION OF ABDOMINAL SURGERIES (SEE "NHO" AND "CARO" ARTICLES - CPT FOLDER). 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. SINCE THE LAUNCH OF THE DEVICE, (B)(4) CAGES (SCARLET ALT AND SCARLET ALT HL RANGES) HAVE BEEN IMPLANTED AND THIS IS THE 8TH COMPLAINT WE RECEIVE FOR THIS KIND OF ISSUE, (B)(4), THE RATE IS VERY LOW. WE CLOSE THE CASE AS IS WITH NO FURTHER ACTION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, WE RECEIVED A COMPLAINT FROM THE FIELD ((B)(6)), FROM CLINICAL STUDIES, (SEE (B)(4) FOLDER) REPORTING THAT, AROUND 7 MONTHS POSTOPERATIVE, THE PATIENT SUFFERED FROM AN ABDOMINAL WALL EVENTRATION. THE SITE CLASSIFIED THIS EVENT AS POSSIBLY RELATED TO THE PROCEDURE. THE PATIENT UNDERWENT A PARIETAL REPAIR SURGERY ON (B)(6) 2024. THE PATIENT IS DOING FINE. WE REPORT THIS CASE BECAUSE A DEVICE MARKETED IN THE US IN INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146531 SCARLET ALT SECURED LUMBAR ANTERIOR CAGE - HYPERLORDOTIC SCARLET ALT SECURED LUMBAR ANTERIOR CAGE - HYPERLORDOTIC OVD SPINEART SA SCA-LM 20 16-S 6-3418 07640185342071

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female