BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12XX28X9 L5°

    MDR report key: 9408357 · Received December 4, 2019

    Report

    Report Number
    3005180920-2019-01031
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 19, 2019
    Report Date
    December 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630030830631
    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 20 NOVEMBER 2019: LOT 1820087: 60 ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2019. EXPIRATION DATE: 2024-01-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE SURGEON DISCOVERED THE BACK OUT OF THE OBLIQUE INTERBODY FUSION DEVICE PEEK/TI AT L5-S1. THE PATIENT HAD 2 SURGERIES BEFORE. THIS IS THE SECOND EXPERIENCE OF THE BACK OUT FOR THE SAME PATIENT. THE FIRST SURGERY DATE IS UNKNOWN. THE SECOND SURGERY WAS PERFORMED ON AUGUST 23. NO ADDITIONAL INFO IS AVAILABLE AT THE MOMENT. THE SURGEON SUCCESSFULLY REVISED THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205063 MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12XX28X9 L5° INTERVERTEBRAL CAGE MAX MEDACTA INTERNATIONAL SA 1820087 07630030830631

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention