BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15040441 · Received July 18, 2022

    Report

    Report Number
    3005180920-2022-00551
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    June 20, 2022
    Report Date
    July 18, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630040719698
    PMA / PMN Number
    K181970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30-JUN-2022: LOT 1822376: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2019. EXPIRATION DATE: 2024-06-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AND 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT A CAGE WAS BACKING OUT OF DISC SPACE. THE SURGEON REMOVED THE CAGE, CAPS, AND ROD AND IMPLANTED A COMPETITOR EXPANDABLE CAGE. THE EXISTING ROD WAS RE-INSERTED AND NEW CAPS WERE USED TO LOCK IT DOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT DID NOT FOLLOW POST-OP GUIDELINES AND THE PATIENT'S LIFESTYLE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136453 MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI SPINE INTERVERTEBRAL CAGE MAX MEDACTA INTERNATIONAL SA 03.27.139 1822376 07630040719698

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention