BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTIX¿ INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY

    MDR report key: 13091281 · Received December 27, 2021

    Report

    Report Number
    3006340236-2021-00031
    Event Type
    Malfunction
    Date Received
    December 27, 2021
    Date of Event
    December 6, 2021
    Report Date
    December 28, 2021
    Manufacturer
    TITAN SPINE, INC.
    Product Code
    MAX
    UDI-DI
    00763000202880
    PMA / PMN Number
    K201267
    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 A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR LUMBAR SPINAL CANAL STENOSIS. PLIF THERAPY WAS PERFORMED AT L4/5. IT WAS REPORTED THAT DURING THE POSTOPERATIVE FOLLOW-UP IT WAS REVEALED THAT THE CAGE WAS BACKED OUT. THE CAGE HAS PROTRUDED ABOUT 5 MM POSTERIORLY FROM THE POSTERIOR WALL. THERE WAS NO PATIENT SYMPTOM & THE PATIENT WAS UNDER OBSERVATION IN HOSPITAL. THERE ARE NO PLANS FOR ADDITIONAL SURGERY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984730 ADAPTIX¿ INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX TITAN SPINE, INC. 84332409 TM0129297 00763000202880

    Patients

    Seq Age Sex Outcome Treatment
    1 Female