BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSKELETON® TAS

    MDR report key: 8588491 · Received May 7, 2019

    Report

    Report Number
    3006340236-2019-00006
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 8, 2019
    Report Date
    May 7, 2019
    Manufacturer
    TITAN SPINE
    Product Code
    OVD
    PMA / PMN Number
    K111626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR 2312-0214 (A151031) HAS BEEN REVIEWED, FOUND TO BE CONFORMING AND APPROVED FOR INITIAL RELEASE. THERE WAS A REPORTED NON-UNION WITH THE SUBJECT DEVICE. THE IMPLANT DID NOT HAVE SUFFICIENT FUSION, SO A REVISION SURGERY WAS SCHEDULED. THERE WAS NO REPORTED ADVERSE EVENT OR PATIENT PAIN OR INJURY DUE TO THE NON-UNION, AND THE EXPLANTED SUBJECT DEVICE WAS RETURNED FOR TECHNICAL EVALUATION. ENGINEERING TECHNICAL EVALUATION NOTED THE IMPLANT HAS NOTICEABLE WEAR, MOST LIKELY ATTRIBUTABLE TO IMPLANTATION AND REMOVAL OF THE SUBJECT DEVICE. NO PHYSICAL DEFECTS WERE FOUND THAT COULD CONTRIBUTE TO A NON-FUSION. BASED ON THE INVESTIGATION, IT CANNOT BE CONCLUDED THAT THE DEVICE WAS THE CAUSE OF FAILED FUSION. LIKELY CAUSE COULD BE SURGICAL TECHNIQUE IN REGARDS TO ENDPLATE PREPARATION, SIZING, AND PLACEMENT OF DEVICE.

    Description of Event or Problem · 1

    THERE WAS A REPORTED NON-UNION WITH THE SUBJECT DEVICE. A REVISION SURGERY WAS COMPLETED ON (B)(6) 2019 TO IMPLANT A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380740 ENDOSKELETON® TAS IMPLANT OVD TITAN SPINE A151031

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention