BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10553056 · Received September 18, 2020

    Report

    Report Number
    3005180920-2020-00616
    Event Type
    Injury
    Date Received
    September 18, 2020
    Date of Event
    August 21, 2020
    Report Date
    September 18, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630030831881
    PMA / PMN Number
    K133192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2020. LOT 1822005: 70 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2019. EXPIRATION DATE: 29-JAN-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. IN THIS COMPLAINT TWO CAGES OF THE SAME LOT ARE INVOLVED IN THE EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR FEW WEEKS AFTER TWO-LEVEL LUMBAR STABILIZATION SURGERY, THE INTERBODY CAGES WERE FOUND TO BE MOBILE AND THEREFORE REPLACED WITH OBLIQUE ONES. THIS CAN BE DUE TO INSUFFICIENT INTERFERENCE OF THE CAGES WITH THE BONE OR TO EXCESSIVE DISTRACTION BETWEEN THE VERTEBRAL BODIES. THERE IS NO INDICATION LEADING TO SUSPECT A FAULTY DEVICE AS RESPONSIBLE FOR THE NEED TO REOPERATE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO CAGES MOBILIZATION 1 MONTH AFTER THE PRIMARY SURGERY. THE POSTERIOR CAGES WERE REPLACED WITH AN OBLIQUE CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017911 MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI INTERVERTEBRAL CAGE MAX MEDACTA INTERNATIONAL SA 03.27.046 1822005 07630030831881

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention