BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10147519 · Received June 12, 2020

    Report

    Report Number
    3005180920-2020-00320
    Event Type
    Injury
    Date Received
    June 12, 2020
    Date of Event
    May 13, 2020
    Report Date
    June 12, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630030831492
    PMA / PMN Number
    K133192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 MAY 2020: LOT 1921791: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-SEP-2019. EXPIRATION DATE: 2024-09-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED ON THE 12 JUNE 2020 BY MEDACTA MEDICAL AFFAIRS DIRECTOR: ONE OF THE POSTERIOR INTERVERTEBRAL CAGES BACKED OUT IN AN ELDERLY PATIENT FEW WEEKS AFTER PRIMARY SURGERY. CAGE BACKOUT IS A POSSIBLE ADVERSE EVENT FOLLOWING LUMBAR ARTHRODESIS, DESCRIBED IN LITERATURE. FROM THE INFORMATION RECEIVED, WE HAVE NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    PRIMARY SURGERY WAS PERFORMED ON (B)(6). PLIF SURGERY WAS PERFORMED AT L5-S1. THE SURGEON DISCOVERED THE BACKOUT OF ONE CAGE. REVISION SURGERY WAS PERFORMED ON MAY 13. THE SURGEON REMOVED THE BOTH CAGES AND REPLACED WITH THE OBLIQUE CAGES. THE PEDICLE SCREW SYSTEM WAS NOT MEDACTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613552 MECTALIF POSTERIOR (TI PEEK) INTERBODY FUSION DEVICE PEEK/TI SPINE INTERBODY CAGE MAX MEDACTA INTERNATIONAL SA 03.27.007 1921791 07630030831492

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention