BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    REPUBLIC SPINE DARK STAR PEDICLE SCREW SYSTEM

    MDR report key: 11572704 · Received March 25, 2021

    Report

    Report Number
    3011796723-2021-00001
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    March 23, 2021
    Report Date
    March 25, 2021
    Manufacturer
    REPUBLIC SPINE, LLC
    Product Code
    NKB
    PMA / PMN Number
    K181495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE INVESTIGATED THIS EVENT BY REVIEWING THE DESIGN HISTORY RECORDS AND OBTAINING THE MANUFACTURING RECORDS OF THIS SCREW. THE INSPECTION RECORDS FOLLOWED AN AQL AND THE RESULTS INDICATE THAT ALL PRODUCTS WERE CONFORMING. 66 SCREWS WERE RECEIVED IN MARCH OF 2020 AND THESE WERE ACCEPTED IN FINISHED PRODUCT ON (B)(6) 2020. 14 OF THE SCREWS REMAIN IN THE FIELD UN-IMPLANTED, THE REMAINING 52 ARE IMPLANTED IN PATIENTS WITH NO REPORTS OF FAILURE OR ADVERSE EFFECTS. PRIOR TO PRODUCTION RELEASE MECHANICAL TESTING INCLUDED: STATIC COMPRESSION, DYNAMIC COMPRESSION, STATIC TORSION, AXIAL GRIP TESTING, TORSIONAL GRIP TESTING. ALL OF THESE TESTS DID NOT IDENTIFY SEPARATION OF TULIP FROM SCREW AS A FAILURE MODE. THIS EVENT WAS SIMILAR TO AN EVENT REPORTED IN (B)(6) OF 2020, ENGINEERING ANALYZED THE DESIGN WITH A FINITE ELEMENT ANALYSIS. THE INVESTIGATION ESTIMATED THAT A AXIAL FORCE OF 250-400 LBS IS REQUIRED TO SEPARATE THE TULIP FROM THE SCREW. THIS IS LARGER THAN THE MECHANICAL STATIC TEST RESULTS AND WITHIN REASONABLE AVERAGE DAILY LIVING LOADS. FOLLOW UP TO THIS MDR IS NOT ANTICIPATED. BUT THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    SURGERY PERFORMED ON (B)(6). FUSION FROM, BILATERAL PEDICLE SCREWS AND INTERBODY CAGES. SURGEON PERFORMED A STANDARD FOLLOW UP AFTER SURGERY. PATIENT ARRIVED AND STATED THAT THERE WAS NO PAIN AND EVERYTHING FELT FINE. SURGEON ORDERED X-RAYS PER STANDARD PROCEDURE AND DISCOVERED THAT ONE TULIP HAD SEPARATED FROM THE SCREW IN THE LEFT PEDICLE. THE SURGEON, VIA THE REP, CONTACT THE COMPANY TO REPORT THIS ISSUE. THE SURGEON STATED THAT THE PATIENT IS IN GOOD HEALTH AND IS SHOWING SIGNS OF FUSION. SURGEON IS NOT GOING TO PERFORM A CORRECTIVE SURGERY, BUT WILL MONITOR UNTIL HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466833 REPUBLIC SPINE DARK STAR PEDICLE SCREW SYSTEM THORACOLUMBAR PEDICLE SCREW SYSTEM NKB REPUBLIC SPINE, LLC 100005-7540 26084

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR