BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X8 L°

    MDR report key: 7876586 · Received September 14, 2018

    Report

    Report Number
    3005180920-2018-00684
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    August 15, 2018
    Report Date
    September 14, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630030828966
    PMA / PMN Number
    K131671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 SEPTEMBER 2018; LOT 148783: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 MAY 2015. EXPIRATION DATE: 2020-04-14; 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. MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X9 L5° REFERENCE 03.23.052 (K131671); LOT 114895A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 AUGUST 2017. EXPIRATION DATE: 2022-07-23; 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 PATIENT CAME IN COMPLAINING OF PAIN 5 MONTHS AFTER THE PRIMARY SURGERY. THE CAGES HAD MIGRATED. THE SURGEON REVISED THE CAGES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717323 MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X8 L° TRANSFORAMINAL INTERBODY FUSION DEVICE MAX MEDACTA INTERNATIONAL SA 148783 07630030828966

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention