BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTIX INTERBODY SYSTEM WITH TITAN NANOLOCK SURFACE TECHNOLOGY

    MDR report key: 11731170 · Received April 27, 2021

    Report

    Report Number
    3006340236-2021-00009
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 27, 2021
    Manufacturer
    TITAN SPINE INC.
    Product Code
    MAX
    UDI-DI
    00763000202866
    PMA / PMN Number
    K201267
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN IMPLANT USED FOR TLIF THERAPY. IT WAS REPORTED THAT THE SUPERIOR SET SCREW ON THE RIGHT SIDE OF THE PATIENT WAS CROSS-THREADED WHEN BROKE OFF. THIS ALLOWED THE ROD TO MOVE FREELY WITHIN THE SCREW HEAD. THIS LACK OF PROPER COMPRESSION ALLOWED FOR THE CAGE TO SUBSIDE. PATIENT OUTCOME WAS THAT SURGEON EXTRACTED THE TLIF CAGE AND THEN DID AN OLIF AT THE CORRESPONDING LEVEL WITH A DIVERGENCE-L CAGE AND A DIVERGENCE PLATE AND SCREWS. THE TLIF CAGE WAS REMOVED AND THEN DID AN OLIF AT THE SAME LEVEL. THE CAGE SUBSIDED POSTERIORLY INTO THE PATIENTS SPINAL COLUMN. NO NEUROLOGICAL DAMAGE OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630420 ADAPTIX INTERBODY SYSTEM WITH TITAN NANOLOCK SURFACE TECHNOLOGY INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX TITAN SPINE INC. 84332407 TM0126900 00763000202866

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention