BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEX-D2

    MDR report key: 19914061 · Received August 5, 2024

    Report

    Report Number
    3010020754-2024-00001
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    August 23, 2023
    Manufacturer
    NEXT ORTHOSURGICAL
    Product Code
    NKB
    PMA / PMN Number
    K190981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCTION LOT RECORDS WERE REVIEWED AND THERE WERE NO ABNORMALITIES INDICATING MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS. THERE ARE NO TRENDS OR ADDITIONAL ADVERSE EVENTS FOR THIS PRODUCT TYPE OR SPECIFIC PRODUCTION LOT. AFTER A REVIEW OF THE REPORTED INFORMATION AND THE SUPPLEMENTAL POST-IMPLANTATION X-RAY, IT WAS DETERMINED THAT THE ROD UTILIZED IN THE (B)(6) 2023 PROCEDURE AS PART OF THE CONSTRUCT AT WHICH THE REPORTED DEVICE WAS FOUND MIGRATED WAS NOT MEASURED AT AN APPROPRIATE SIZE. THE RODS SHOULD TYPICALLY ONLY EXTEND 2-10MM PAST THE FINAL SCREW. THE ROD PRESENTED IN THE X-RAY IS SHOWN TO APPEAR MORE THAN 20MM. IF ADJACENT ANATOMY BLOCKED THE EXTENDED ROD FROM BEING FULLY SEATED INTO THE POLYAXIAL SCREW TULIP, THEN THE FINAL TIGHTENING TORQUE OF THE SET SCREW MAY HAVE BEEN REACHED PREMATURELY. POST-OPERATIVE MOTION COULD THEREFORE ALLOW THE ROD TO MOVE WITHIN THE OPEN SPACE IN THE TULIP AND LOOSEN THE SET SCREW. THE ANATOMY OF THE ADJACENT VERTEBRA AND LIGAMENTS MAY ADDITIONALLY LEVER UNDUE FORCE ON THE EXTENDED END OF THE ROD, FURTHER CAUSING THE SET SCREW TO COME LOOSE. FROM THE X-RAYS, THERE ARE NO INTERBODY SPACERS IN THE SPACES OF L4-L5 AND L6-S1. WITH NO INTERBODY SPACERS, THE ROD FASTENED ACROSS THAT VERTEBRAL LEVEL RECEIVES UNDUE STRESS WHICH COULD LEAD TO SCREWS OR FASTENERS LOOSENING. THE INSTRUCTIONS FOR USE DESCRIBE THE INCREASED RISK OF DEVICE FAILURE WITHOUT SUPPORTING SPACER STRUCTURES. IN THE SECOND SCHEDULED OPERATION IN WHICH THE L5 SCREWS WERE REPLACED- INSTRUCTIONS FOR USE STATE THAT PRIOR FUSION AT THE SAME LEVELS TO BE TREATED IS CONTRAINDICATED. RISKS DESCRIBED IN THE INSTRUCTIONS FOR USE INCLUDE DIFFERENT CLINICAL OUTCOMES FOR PATIENTS THAT UNDERGO ADDITIONAL SURGERIES AT THE SAME LEVELS TO BE TREATED. THE FAILURE WAS CAUSED BY AN OVERAGE OF STRESS APPLIED AT THE AREA OF THE EXCESSIVELY LENGTHENED ROD, FORCING THE SET SCREW FASTENER TO EGRESS. BASED ON THE INVESTIGATION, THE ROOT CAUSE HAS BEEN ATTRIBUTED TO A USER RELATED ISSUE. IF FURTHER INFORMATION IS PROVIDED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE INITAL OPERATION WAS PERFORMED FROM L3 TO L5 USING PLIF TECHNIQUE. IT WAS STATED THAT THE PATIENT HAS A 6TH LUMBAR VERTEBRA. ON (B)(6) 2023, A SECOND SCHEDULED OPERATION WAS PERFORMED USING PLIF. DURING THIS OPERATION, THE L5 POLYAXIAL SCREWS WERE REPLACED AND POLYAXIAL SCREWS WERE ADDED TO L6. THE ROD SIZES WERE 100MM ON ONE SIDE AND 125MM ON THE OTHER. FROM EXAMINING THE X-RAY PROVIDED, THE 125MM ROD EXTENDS UPWARDS PAST L3 INTO L2. IT WAS STATED THAT THE 125MM ROD WAS CHOSEN BECAUSE THE PATIENT WAS NOT ACTIVE. ON (B)(6) 2023, IT WAS DISCOVERED VIA X-RAY THAT ONE SET SCREW ATOP ONE OF THE L3 POLYAXIAL SCREWS HAD COME OFF. IT WAS STATED THAT THE PATIENT DID NOT COMPLAIN OF ANY PAIN. ON THE SAME DATE, AN OPERATION WAS PERFORMED TO REMOVE AND REPLACE THIS SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703097 NEX-D2 SET SCREW, BLUNT START NKB NEXT ORTHOSURGICAL CBCAJ-10000 U022366A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention