BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STALIF C ABO SCREW, 4.0MM DIA X 14MM (TI)

    MDR report key: 11869830 · Received May 24, 2021

    Report

    Report Number
    3007494564-2021-00041
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 20, 2021
    Manufacturer
    CENTINEL SPINE, LLC.
    Product Code
    OVE
    UDI-DI
    00815101029016
    PMA / PMN Number
    K133200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A PATIENT RECEIVED 3 LEVELS OF STALIF C-TI DEVICES ON (B)(6) 2021. DEVICES WERE IMPLANTED AT C3/4, C5/6, AND C6/7. ABOUT 2 MONTHS AFTER IMPLANTATION, CENTINEL WAS MADE AWARE OF A C6 VERTEBRAL COLLAPSE BETWEEN 2 OF THE STALIF C-TI CAGES. THE PATIENT WAS REVISED TO A C6 CORPECTOMY VIA EXPLANTATION OF THE STALIF C-TI CAGES AND SCREWS AT C5/6 AND C6/7. THERE WAS NO INDICATION THAT C3/4 WAS REVISED. THE REVISING SURGEON BELIEVED THE COLLAPSED VERTEBRAE WAS DUE TO PATIENT ANATOMY; HOWEVER, THE DEVICES COULD NOT BE RULED OUT AS CONTRIBUTORY. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. DHR REVIEW FOR THE INVOLVED IMPLANTS DID NOT FIND ANY ISSUES DURING MANUFACTURING WHICH MAY HAVE CAUSED OR CONTRIBUTED. THE RATE OF COMPLAINTS WAS DETERMINED TO BE ACCEPTABLE AND WITHIN THE ALLOWABLE LIMITS OF THE RISK ASSESSMENT FOR THE DEVICES. THE RISK ASSESSMENT HAS IDENTIFIED THE RISKS OF VERTEBRAL COLLAPSE WITH THE USE OF STALIF C-TI CAGES AND SCREWS. NO DEVICE WAS RETURNED FOR EVALUATION. THIS SUBMISSION IS FOR 1 DEVICE OUT OF 12 DEVICES INVOLVED IN TOTAL. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED FROM THE PATIENT OR REMAIN IMPLANTED, THUS ALL DEVICES INVOLVED WERE REPORTED.

    Description of Event or Problem · 1

    A PATIENT RECEIVED 3 LEVELS OF STALIF C-TI INTERBODY CAGES AND ABO SCREWS AT C3/4, C5/6, AND C6/7 ON (B)(6) 2021. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH A COLLAPSED C6 VERTEBRAE IDENTIFIED VIA LATERAL X-RAY. ON (B)(6) 2021, THE PATIENT WAS REVISED TO A C6 CORPECTOMY BY REMOVAL OF 2 OF THE 3 STALIF C-TI CAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769313 STALIF C ABO SCREW, 4.0MM DIA X 14MM (TI) INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL OVE CENTINEL SPINE, LLC. ABS1440 2020-0545 00815101029016

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention| S