BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 13513696 · Received February 11, 2022

    Report

    Report Number
    3005180920-2022-00087
    Event Type
    Injury
    Date Received
    February 11, 2022
    Date of Event
    January 15, 2022
    Report Date
    February 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630030831881
    PMA / PMN Number
    K133192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 JANUARY 2022. LOT 1920666: (B)(4). EXPIRATION DATE: 2025-JUL-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). IN THIS CASE, TWO DEVICES WITH THE SAME LOT NUMBERS WERE REPORTED, HOWEVER, ONLY ONE MOBILIZED (UNKNOWN WHICH ONE). CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. FEW WEEKS AFTER MULTI-LEVEL LUMBAR STABILIZATION SURGERY WITH PEDICLE SCREWS AND POSTERIOR CAGES, ONE OF THE CAGES AT LOWER LEVEL BACKS OUT. IT MAY REQUIRE REVISION AT LATER STAGE. SPONTANEOUS CAGE BACK OUT IS A POSSIBLE ADVERSE EVENT FOLLOWING LUMBAR STABILIZATION, VASTLY DESCRIBED IN LITERATURE; THE CAUSE IS OFTEN LINKED TO INSUFFICIENT COMPRESSION OR LOSS OF COMPRESSION BEWTWEEN VERTEBRAE. NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS COMPLAINT.

    Description of Event or Problem · 0

    L1 / L2 / L3 / L4 / L5 FIXATION SURGERY WAS PERFORMED ON (B)(6) 2021. THE SURGEON NOTICED THE CAGE BACK OUT BY X-RAY IMAGES ON (B)(6) 2022. THERE WAS NO PROBLEM WITH THE X-RAY IMAGE IMMEDIATELY AFTER THE SURGERY. THE PATIENT IS CURRENTLY ASYMPTOMATIC. TWO CAGES WERE REPORTED, IT IS UNKNOWN WHICH ONE HAS BACKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81680 MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI SPINE POSTERIOR CAGE MAX MEDACTA INTERNATIONAL SA 03.27.046 1920666 07630030831881

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other