BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12098252 · Received July 1, 2021

    Report

    Report Number
    3005180920-2021-00537
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    June 3, 2021
    Report Date
    July 1, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630040719452
    PMA / PMN Number
    K181970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 JUNE 2021: LOT 1922752: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2019. EXPIRATION DATE: 2024-11-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 3 SIMILAR REPORTED EVENTS. NOTE THAT TWO EQUAL DEVICES WERE REPORTED IN THIS CASE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN AND POST-OP X-RAYS INDICATED THAT THE CAGES HAD EJECTED POSTERIORLY. THE PATIENT WILL BE REVISED AND THE DATE OF THE REVISION IS UNKNOWN. NO MORE INFORMATION WILL BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996041 MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI INTERBODY VERTEBRAL CAGE MAX MEDACTA INTERNATIONAL SA 1922752 07630040719452

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention