BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF ANTERIOR SYSTEM

    MDR report key: 21968730 · Received May 6, 2025

    Report

    Report Number
    3005180920-2025-00376
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 5, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    UDI-DI
    07630030834011
    PMA / PMN Number
    K160605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16-APR-2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2022. EXPIRATION DATE: 17-MAR-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED: MECTALIF ANTERIOR 03.30.202 MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.14 MM (K124034) LOT. 2329503 BATCH REVIEW PERFORMED ON 16-APR-2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JAN-2024. EXPIRATION DATE: 03-JAN-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MECTALIF ANTERIOR 03.30.133 MECTALIF ANTERIOR CAGE - ENH SCREW DIAM.5X35 (2X) (K160605) LOT. 2228561 BATCH REVIEW PERFORMED ON 16-APR-2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APR-2023. EXPIRATION DATE: 13-MAR-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT: A REVISION SURGERY WAS PERFORMED APPROXIMATELY 10 DAYS AFTER THE PRIMARY ALIF (ANTERIOR LUMBAR INTERBODY FUSION) PROCEDURE. THE PATIENT REPORTED PAIN, PROMPTING A FOLLOW-UP CT SCAN, WHICH REVEALED THAT THE LOWER SCREWS SECURING THE ANTERIOR PLATE WERE EXCESSIVELY LONG, BREACHING THE SACRAL CANAL AND IMPINGING ON THE S1 NERVE ROOT. THIS COMPLICATION MAY HAVE BEEN FACILITATED BY SUBOPTIMAL POSITIONING OF THE INTERBODY CAGE, WHICH WAS NOT PERFECTLY CENTERED ON THE VERTEBRAL ENDPLATE. WE DO NOT HAVE REASONS TO SUSPECT A DEFECTIVE DEVICE. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, ALTHOUGH IT IS POSSIBLE THAT THE SUBOPTIMAL POSITIONING OF THE CAGE COULD HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT FEW DAYS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN. FROM THE TAC IT WAS VISIBLE THAT THE SCREW IMPLANTED WAS NEAR TO S1 ROOT. DURING THE REVISION, BECAUSE THE HEAD OF THE SCREW TO BE REVISED WAS STRIPPED, ALL THE IMPLANTS HAD TO BE REMOVED AND A NEW CAGE, SCREWS AND PLATE PUT IN. SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895584 MECTALIF ANTERIOR SYSTEM MECTALIF ANTERIOR STAND-ALONE TIPEEK CAGE 27X35X14 LORDOSIS 15° OVD MEDACTA INTERNATIONAL SA 03.31.028 2220166 07630030834011

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention