BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCARLET ALT SECURED LUMBAR ANTERIOR CAGE - HYPERLORDOTIC

    MDR report key: 20843059 · Received December 4, 2024

    Report

    Report Number
    3007728266-2024-00017
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    February 1, 2024
    Report Date
    December 4, 2024
    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) 2022. 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 (B)(6) HAVE BEEN IMPLANTED AND THIS IS THE 7TH COMPLAINT WE RECEIVE FOR THIS KIND OF ISSUE, WHICH REPRESENTS (B)(4) OF ISSUE, THE RATE IS VERY LOW. WE CLOSE THE CASE AS IS WITH NO FURTHER ACTION.

    Description of Event or Problem · 0

    ON (B)(6) 2024, WE RECEIVED AN UPDATED COMPLAINT FROM THE FIELD, FROM CLINICAL STUDIES, (B)(4) REPORTING THAT, FOLLOWING A SURGERY REALIZED ON (B)(6) 2023 (ALIF - L5S1 - (B)(6), - ALIF - L4L5 - (B)(6), TDR - L3L4 - PRODISC L), THE PATIENT SUFFERED FROM AN ABDOMINAL WALL EVENTRATION WHICH STARTED ON (B)(6) 2024 (AROUND 3 MONTHS PO) AND WAS CONSIDERED AS AN ADE AS PER SITE AND SPONSOR ASSESSMENT (RELATIONSHIP TO PROCEDURE) WITH MODERATE SEVERITY. A RE-INTERVENTION WAS DECIDED, AND A PARIETAL REPAIR SURGERY WAS REALIZED ON (B)(6) 2024. THE EVENT WAS CLASSIFIED AS RESOLVED ON (B)(6) 2024. AS PER SITE, THE EVENT IS NOT RELATED TO STUDY DEVICE OR TO A "DEVICE" INSTRUMENT, BUT POSSIBLY RELATED TO THE PROCEDURE. THIS AE IS NOT ASSOCIATED WITH A DEVICE DEFICIENCY. WE REPORT THIS CASE BECAUSE A DEVICE MARKETED IN THE US IN INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871261 SCARLET ALT SECURED LUMBAR ANTERIOR CAGE - HYPERLORDOTIC SCARLET ALT SECURED LUMBAR ANTERIOR CAGE - HYPERLORDOTIC OVD SPINEART SA SCA-LM 20 16-S 6-5438 07640185342071

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female