BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCARLET ALT SECURED LUMBAR ANTERIOR CAGE

    MDR report key: 19593704 · Received June 24, 2024

    Report

    Report Number
    3007728266-2024-00007
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    October 4, 2021
    Report Date
    June 25, 2024
    Manufacturer
    SPINEART SA
    Product Code
    OVD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED A COMPLAINT ON 03.JUN.2024, REPORTING THAT, THE PATIENT UNDERWENT A SURGERY ON L5/S1 AND L4/L5 -ANTERIOR APPROACH- ON (B)(6) 2021 (SURGERY INDICATION: DEGENERATIVE DISC DISEASE). 2 CAGES WERE IMPLANTED, AND 6 SCREWS WERE IMPLANTED WITH NO COMPLICATION. THERE IS NO OTHER MEDICAL HISTORY, BUT 1 PREVIOUS SPINE SURGERY WAS REPORTED (DISCECTOMY L4/L5 WITH INTERSPINOUS DEVICE PERFORMED IN 2013). AS PER THE CASE NARRATIVE, THE PATIENT PRESENTED A DISCOMFORT AT THE LEVEL OF THE SUBUMBILICAL SCAR STARTING ON (B)(6) 2021. THE INTENSITY DEGREE OF THE SERIOUS ADVERSE EVENT (SAE) "INCISIONAL HERNIA AT UMBILICAL LEVEL" WAS CLASSIFIED AS "MODERATE". A RE-INTERVENTION "PARIETAL REPAIR SURGERY" WAS PERFORMED ON (B)(6) 2021. IT WAS A HERNIA SUTURE REPAIR (VICRYL), AND NO MESH WAS USED. THE OUTCOME OF THE SAE WAS REPORTED AS "RESOLVED". THE END DATE WAS (B)(6) 2022. THE CAUSAL RELATIONSHIP OF THIS EVENT TO THE PROCEDURE WAS CLASSIFIED AS "PROBABLE", AND TO DEVICE OR INSTRUMENT CLASSIFIED AS "NOT RELATED" BY THE REPORTING INVESTIGATOR. 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. SCIENTIFIC LITERATURE REPORTS THAT VENTRAL HERNIA IS COMMON COMPLICATION OF ABDOMINAL SURGERIES. 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, 18229 CAGES HAVE BEEN IMPLANTED AND THIS IS THE SIXTH 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. BECAUSE OF RE-INTERVENTION SURGERY (NO EXPLANTATION) WE DECIDED TO INFORM FRENCH NATIONAL COMPETENT AUTHORITY VIA MIR-12-2024 AND TO INFORM FDA VIA MDR-07-2024 BECAUSE THE DEVICES INVOLVED ARE US MARKETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    ON 03.JUN.2024, WE RECEIVED A COMPLAINT FROM THE FIELD (SEE (B)(4) FOLDER) REPORTING THAT THE PATIENT UNDERWENT A SPINE SURGERY ON L4/L5 AND L5/S1 ON (B)(6) 2021. THE PATIENT PRESENTED A DISCOMFORT AT THE LEVEL OF SUB-UMBILICAL SCAR STARTING ON (B)(6) 2021 (INCISIONAL HERNIA AT UMBILICAL LEVEL), THE INTENSITY DEGREE OF THE ADVERSE EVENT WAS CLASSIFIED AS MODERATE. A RE-INTERVENTION "PARIETAL REPAIR SURGERY" WAS PERFORMED ON (B)(6) 2021. IT WAS A HERNIA SUTURE REPAIR AND NO MESH WAS USED. THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS REPORTED AS RESOLVED, THE END DATE WAS (B)(6) 2022. WE REPORT THIS CASE BECAUSE THE SURGERY INVOLVED DEVICES MARKETED IN THE US.

    Description of Event or Problem · 0

    ON 03.JUN.2024, WE RECEIVED A COMPLAINT FROM THE FIELD (SEE CPT-3039 FOLDER) REPORTING THAT THE PATIENT UNDERWENT A SPINE SURGERY ON L4/L5 AND L5/S1 ON (B)(6) 2021. THE PATIENT PRESENTED A DISCOMFORT AT THE LEVEL OF SUB-UMBILICAL SCAR STARTING ON (B)(6) 2021 (INCISIONAL HERNIA AT UMBILICAL LEVEL) , THE INTENSITY DEGREE OF THE ADVERSE EVENT WAS CLASSIFIED AS MODERATE. A RE-INTERVENTION "PARIETAL REPAIR SURGERY" WAS PERFORMED ON (B)(6) 2021. IT WAS A HERNIA SUTURE REPAIR AND NO MESH WAS USED. THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS REPORTED AS RESOLVED, THE END DATE WAS (B)(6) 2022. WE REPORT THIS CASE BECAUSE THE SURGERY INVOLVED DEVICES MARKETED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577090 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 5-7342 AND 5-5169

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention