BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI

    MDR report key: 17001454 · Received May 25, 2023

    Report

    Report Number
    3005180920-2023-00368
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    April 27, 2023
    Report Date
    May 25, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630040719438
    PMA / PMN Number
    K181970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 APRIL 2023. LOT 2124065: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-DEC-2021. EXPIRATION DATE: 2026-DEC-02. 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. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE CAGE 03.27.113 LOT 2124965 DOESN'T PRESENT EVIDENT CRACKS OR DAMAGE EITHER ON THE BODY OR ON THE PYRAMIDS. THE CAGE 03.27.034 LOT 148855A PRESENTS SOME SCRATCHES AND COATING DELAMINATION ON THE POSTERIOR SIDE OF THE IMPLANT AND THE THREAD IS DAMAGED AT THE VERY BEGINNING. THE PYRAMIDS APPEAR DAMAGED ON ONE OF THE ENDPLATES WHILE THE ONES ON THE OTHER ARE NOT. ACCORDING TO THE INFORMATION PROVIDED THE FECECTOMY WAS PERFORMED ONLY ON THE RIGHT SIDE AND THEN BOTH IMPLANTS WERE INSERTED (IN ORDER, THE PLIF 11MM & THEN THE PLIF 9MM). THE ROOT CAUSE OF THE COMPLAINT COULD BE RELATED TO THE NON-SUFFICIENT COMPRESSION APPLIED TO THE IMPLANTS. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FEW WEEKS AFTER 2-LEVEL PRIMARY STABILIZATION SURGERY WITH PEDICLE SCREWS AND CAGES, ONE OF THE POSTERIOR CAGES BACKS OUT. AT L4-L5, POSTERIOR CAGES WERE CHOSEN. ONE HAD A WIDTH OF 11 MM AND ONE OF 9. THE NARROWER BACKED OUT IN FEW WEEKS. THE MOST PLAUSIBLE CAUSES FOR CAGE MIGRATION INCLUDE INSUFFICIENT COMPRESSION, PATIENT BEHAVIOUR, DIFFICULTIES IN PLATE PREPARATION. NO REASON TO SUSPECT A FAULTY DEVICE. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 2 MAY 2023. MECTALIF POSTERIOR (TI PEEK) 03.27.034 POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X10 L5° (K133192) LOT. 148855A. LOT 148855A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2021. EXPIRATION DATE: 2026-FEB-03. 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.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO CAGES MIGRATION IN L4-L5, ABOUT 1 MONTH AFTER THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848656 MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI POSTERIOR INTERBODY FUSION DEVICE PEEK/TI MAX MEDACTA INTERNATIONAL SA 03.27.113 2124965 07630040719438

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention