BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STALIF MIDLINE ABO SCREW 6 X 25MM

    MDR report key: 11771861 · Received May 4, 2021

    Report

    Report Number
    3007494564-2021-00027
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    October 4, 2019
    Report Date
    May 3, 2021
    Manufacturer
    CENTINEL SPINE, LLC.
    Product Code
    OVD
    UDI-DI
    00815101029290
    PMA / PMN Number
    K141942
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED HAS BEEN PROVIDED DIRECT FROM THE PATIENT. THE PATIENT INDICATED THEY RECEIVED A STALIF MIDLINE II-TI ALIF USING A MIDLINE II-TI CAGE AND 3 MIDLINE SCREWS ON (B)(6) 2019. THE FUSION FAILED RESULTING IN A PSEUDOARTHROSIS AND CONTINUED PAIN. THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO ADD POSTERIOR FUSION WITH UNKNOWN DEVICES ON AN UNKNOWN DATE. THIS ADDITIONAL SURGERY WAS INTENDED TO ADDRESS THE FAILED FUSION. ACCORDING TO THE PATIENT'S INFORMATION, THE PATIENT AND SURGEON BELIEVE THE ATTEMPTED ALIF FAILED BECAUSE OF THE PEEK MATERIAL USED TO MANUFACTURE THE STALIF MIDLINE II-TI CAGE. THE HYDROPHOBIC PROPERTIES OF THE PEEK MATERIAL DID NOT ALLOW THE BONE GRAFT TO OSTEO-INTEGRATE WITH THE CAGE. ADDITIONALLY THE PATIENT BELIEVES THEY HAVE A METAL ALLERGY. THE PATIENT ORDERED AN IMPLANT MATERIAL PANEL TO TEST MULTIPLE MATERIALS FOR AN ALLERGIC REACTION. AS OF THIS SUBMISSION, THE RESULTS OF THAT ALLERGY PANEL ARE UNKNOWN. DHR REVIEW OF THE CAGE AND SCREWS INVOLVED DID NOT FIND ANY PROBLEMS DURING MANUFACTURING RELATED TO THIS EVENT. COMPLAINT HISTORY SUGGESTS THE RATE OF BOTH FAILED FUSION/PSEUDOARTHROSIS AND ALLERGIC REACTION ARE VERY LOW, AND WITHIN THE ALLOWABLE LIMITS OF THE DEVICES RISK ASSESSMENTS. THE RISKS ASSOCIATED WITH PSEUDOARTHROSIS AND ALLERGIC REACTION ARE IDENTIFIED, MITIGATED, AND DETERMINED TO BE ACCEPTABLE. AS OF THIS SUBMISSION THE DEVICES REMAIN IMPLANTED THUS NO EVALUATION OF THE DEVICES INVOLVED HAS BEEN PERFORMED. IF THE RESULTS OF THE ALLERGY TESTING PANEL ARE MADE AVAILABLE AT A LATER DATE, A FOLLOW UP SUBMISSION WILL BE COMPLETED. THIS SUBMISSION IS FOR 1 OF 4 DEVICES INVOLVED.

    Description of Event or Problem · 1

    A PATIENT RECEIVED A STALIF MIDLINE II-TI CAGE AND STALIF MIDLINE SCREWS ON (B)(6) 2019. THE ALIF PROCEDURE RESULTED IN A FAILED FUSION AND CONTINUED PATIENT PAIN. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO ADD POSTERIOR FUSION ON AN UNKNOWN DATE. ACCORDING TO THE INFORMATION FROM THE PATIENT, THE SURGEON INFORMED THE PATIENT THAT THE FAILED FUSION MAY BE DUE TO THE PEEK MATERIAL USED TO MAKE THE CAGE. THE PATIENT ALSO SUSPECTS THEY HAVE AN ALLERGY TO METALS USED IN THE IMPLANTS. AS OF THIS REPORT, THE ALLERGY COULD NOT BE CONFIRMED DESPITE THE PATIENT UNDERGOING A IMPLANT MATERIAL ALLERGY PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667082 STALIF MIDLINE ABO SCREW 6 X 25MM INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD CENTINEL SPINE, LLC. STM6025 2018-876 00815101029290

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention