BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF ANTERIOR STAND-ALONE TIPEEK CAGE 24X31X12 LORDOSIS 5°

    MDR report key: 7578042 · Received June 7, 2018

    Report

    Report Number
    3005180920-2018-00404
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    May 11, 2018
    Report Date
    June 7, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    UDI-DI
    07630030833755
    PMA / PMN Number
    K160605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 JUNE 2018: LOT 140670: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JANUARY 2015. EXPIRATION DATE: 2019-12-31 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

    DURING AN L4-S1 ALIF CASE, WHEN THE SURGEON WAS TRIALING THE CAGE HE INFORMED THE SALES AGENT THAT HE DOES NOT LIKE THE SHAPE OF THE TRIALS/IMPLANT. THE SURGEON DOWNSIZED THE CAGE AND IMPLANTED A 24X31X12 BECAUSE THE CAGES ARE TOO SQUARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423165 MECTALIF ANTERIOR STAND-ALONE TIPEEK CAGE 24X31X12 LORDOSIS 5° TIPEEK CAGE OVD MEDACTA INTERNATIONAL SA 140670 07630030833755

    Patients

    Seq Age Sex Outcome Treatment
    1 Other