BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTIX¿ INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY

    MDR report key: 13058540 · Received December 22, 2021

    Report

    Report Number
    3006340236-2021-00030
    Event Type
    Injury
    Date Received
    December 22, 2021
    Report Date
    December 22, 2021
    Manufacturer
    TITAN SPINE, INC.
    Product Code
    MAX
    UDI-DI
    00763000202873
    PMA / PMN Number
    K201267
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLIF SPINAL THE RAPY AT L4/5 FOR LCS. IT WAS REPORTED THAT APPROXIMATELY 2 MM THE CAGE BACKED OUT. AS AN ADDITIONAL SURGERY THE CAGE WAS REMOVED AND ILIUM INSERTED. THE SCREWS ON BOTH SIDES OF L5 BECAME LOOSE. THE PATIENT HAS A FEVER AND IS SUSPECTED OF BEING INFECTED. THERE WAS NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965315 ADAPTIX¿ INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX TITAN SPINE, INC. 84332408 TM0129363 00763000202873

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention