BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCARLET ALT SECURED LUMBAR ANTERIOR CAGE

    MDR report key: 19594088 · Received June 24, 2024

    Report

    Report Number
    3007728266-2024-00008
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    October 8, 2021
    Report Date
    June 27, 2024
    Manufacturer
    SPINEART SA
    Product Code
    OVD
    UDI-DI
    07640178988057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    AS PER THE CASE NARRATIVE, THE PATIENT COMPLAINED ABOUT CHILLS AND ABDOMINAL PAIN BEGINNING OF (B)(6) 2021 AND A PREVERTEBRAL FLUID COLLECTION IN FRONT OF L4/L5 PROSTHESIS (PRODISC-L) WAS DISCOVERED ON (B)(6) 2021. THE INTENSITY DEGREE OF THE ADVERSE EVENT (AE) WAS CLASSIFIED AS "MODERATE". A RE-INTERVENTION WAS PERFORMED ON (B)(6) 2021 TO REMOVE THE PREVERTEBRAL ABSCESS. THE OUTCOME OF THE SAE WAS REPORTED AS "RESOLVED". THE END DATE WAS (B)(6) 2021. THE CAUSAL RELATIONSHIP OF THIS EVENT TO THE PROCEDURE WAS CLASSIFIED AS "CAUSAL", 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. (B)(4).. SCIENTIFIC LITERATURE REPORTS (NATIONAL LIBRARY OF MEDICINE) THAT SEROMA IS A COMMON COMPLICATION OF ABDOMINAL SURGERIES, SEE POSTOPERATIVE SEROMA MANAGEMENT - STATPEARLS - NCBI BOOKSHELF (NIH.GOV) "SEROMA IS THE ABNORMAL ACCUMULATION OF SEROUS FLUID IN A DEAD SPACE CONTAINING PLASMA AND LYMPHATIC FLUID.[1][2][3] IT IS A COMMON COMPLICATION OF BREAST CANCER SURGERY, PLASTIC SURGERY, AND ABDOMINAL WALL HERNIA REPAIR, WITH RATES RANGING BETWEEN 15 TO 85% FOLLOWING MASTECTOMY AND A GLOBAL PREVALENCE OF 10.9% FOLLOWING ABDOMINOPLASTY.[4][5][6] SURGICAL PROCEDURES WITH EXTENSIVE SOFT TISSUE DISSECTION ARE MORE LIKELY TO TRANSECT BLOOD AND LYMPHATIC VESSELS AND LEAD TO A TRANSUDATIVE FLUID COLLECTION. CASES THAT HAVE UNDERGONE SIGNIFICANT RESECTION OF TISSUE RESULT IN A LARGE POTENTIAL DEAD SPACE, MAKING IT MORE DIFFICULT FOR FLAPS TO ADHERE AND CREATING SHEARING FORCES BETWEEN TISSUE SURFACES. THIS IS THOUGHT TO CONTRIBUTE TO AN INFLAMMATORY PROCESS WITH EXUDATIVE FLUID FROM TISSUES ADDING TO SEROMA FORMATION". PLUS, SEROMA IS PART OF THE GENERAL ADVERSE EVENTS LISTED IN THE CLINICAL EVALUATION REPORT (CER) (B)(4). BASED ON THE ABOVE INFORMATION, WE CONFIRM 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). WE CLOSE THE CASE AS IS WITH NO FURTHER ACTION.

    Description of Event or Problem · 0

    ON 03.JUN.2024, WE RECEIVED A COMPLAINT FROM THE FIELD, FROM FRANCE, (SEE (B)(4) FOLDER) REPORTING THAT THE PATIENT UNDERWENT A SPINE SURGERY ON L4/L5 (NOT SPINEART DEVICE) AND L5/S1 (SPINEART DEVICE) ON (B)(6) 2021. BEGINNING OF (B)(6) 2021, THE PATIENT HAD CHILLS AND ABDOMINAL PAIN, PREVERTEBRAL FLUID COLLECTION IN FRONT OF L4/L5 PROSTHESIS (PRODISC-L) WAS DISCOVERED ON (B)(6) 2021. THE INTENSITY DEGREE OF THE ADVERSE EVENT WAS CLASSIFIED AS MODERATE. A RE-INTERVENTION WAS PERFORMED ON (B)(6) 2021 TO REMOVE THE PREVERTEBRAL ABSCESS. THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2021. WE REPORT THIS CASE AS THE DEVICE INVOLVED IS US MARKETED.

    Description of Event or Problem · 0

    ON 03.JUN.2024, WE RECEIVED A COMPLAINT FROM THE FIELD, FROM (B)(6) , (SEE (B)(4) FOLDER) REPORTING THAT THE PATIENT UNDERWENT A SPINE SURGERY ON L4/L5 (NOT SPINEART DEVICE) AND L5/S1 (SPINEART DEVICE) ON (B)(6) 2021. BEGINNING OF (B)(6) 2021, THE PATIENT HAD CHILLS AND ABDOMINAL PAIN, PREVERTEBRAL FLUID COLLECTION IN FRONT OF L4/L5 PROSTHESIS (PRODISC-L) WAS DISCOVERED ON (B)(6) 2021. THE INTENSITY DEGREE OF THE ADVERSE EVENT WAS CLASSIFIED AS MODERATE. A RE-INTERVENTION WAS PERFORMED ON (B)(6) 2021 TO REMOVE THE PREVERTEBRAL ABSCESS. THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2021. WE REPORT THIS CASE AS THE DEVICE INVOLVED IS US MARKETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604260 SCARLET ALT SECURED LUMBAR ANTERIOR CAGE SCARLET ALT SECURED LUMBAR ANTERIOR CAGE OVD SPINEART SA SCA-LS 15 12-S 5-0628 07640178988057

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention