BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVICTUS SPINAL FIXATION SYSTEM

    MDR report key: 21939559 · Received April 30, 2025

    Report

    Report Number
    2027467-2025-00063
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 30, 2025
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    NKB
    UDI-DI
    00190376269719
    PMA / PMN Number
    K192938
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D4. MODEL #: 15100. CATALOG #: 15100. LOT #: SM153276. PRIMARY UDI: (B)(4). G4. PMA/510(K): K181677. H3. YES. H4. 02/11/2023. H6. COMPONENT CODE: 568. INVESTIGATION FINDINGS: 3207, 3243. INVESTIGATION CONCLUSIONS: 19, 61. DEVICE EVALUATION: ON THE LEFT SIDE OF THE CONSTRUCT, ALL SET SCREWS HAD A CONSISTENT AND SYMMETRIC WEAR PATTERN. THIS WEAR PATTERN INDICATES THAT THE SET SCREW WAS FULLY NORMALIZED TO THE ROD AND THE SCREWS. ON THE RIGHT SIDE OF THE CONSTRUCT, TWO OF THE THREE SET SCREWS SHOW A SIMILAR WEAR PATTERN TO THE SET SCREWS FROM THE LEFT SIDE. ONE OF THE SET SCREWS SHOWS AN ASYMMETRIC WEAR PATTERN. THE ASYMMETRIC WEAR PATTERN INDICATES THAT THE SET SCREW WAS ONLY CONTACTING THE ROD ON ONE SIDE. SET SCREW NON-NORMALIZATION WILL LIKELY LEAD TO SET SCREW BACKING OUT OVER TIME. THE ROOT CAUSE OF THE ISSUE IS THAT THE SCREWS WERE NOT FULLY LOCKED DOWN. A REVIEW OF DEVICE HISTORY SHOWED NO MANUFACTURING OR PROCESSING RELATED IRREGULARITIES. LABELING REVIEW: WARNINGS/CAUTIONS/PRECAUTIONS: RISKS IDENTIFIED WITH THE USE OF THESE DEVICES, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE DEVICE COMPONENT FAILURE, LOSS OF FIXATION/STABILIZATION, NON-UNION, VERTEBRAL FRACTURE, NEUROLOGICAL INJURY, VASCULAR OR VISCERAL INJURY. POSSIBLE ADVERSE EFFECTS: INITIAL OR DELAYED LOOSENING, DISASSEMBLY, BENDING, DISLOCATION, AND/OR BREAKAGE OF DEVICE COMPONENTS. INTRAOPERATIVE MANAGEMENT: FINAL TIGHTENING OF SET SCREWS: ALL SET SCREWS MUST BE TIGHTENED USING THE APPROPRIATE INSTRUMENTS (E.G., TORQUE HANDLE, FINAL DRIVER, AND COUNTER TORQUE) AS INDICATED IN THE SURGICAL TECHNIQUE GUIDE. POSTOPERATIVE MANAGEMENT: THE SURGEON SHOULD INSTRUCT THE PATIENT REGARDING AMOUNT AND TIME FRAME AFTER SURGERY OF ANY WEIGHT BEARING ACTIVITY. THE INCREASED RISK OF BENDING, DISLOCATION, AND/OR BREAKAGE OF THE IMPLANT DEVICES, AS WELL AS AN UNDESIRED SURGICAL RESULT ARE CONSEQUENCES OF ANY TYPE OF EARLY OR EXCESSIVE WEIGHT BEARING, VIBRATORY MOTION, FALL, JOLTS OR OTHER MOVEMENTS PREVENTING PROPER HEALING AND/OR FUSION DEVELOPMENT. IMPLANT DEVICES SHOULD BE REVISED OR REMOVED IF BENT, DISLOCATED, OR BROKEN. IMMOBILIZATION SHOULD BE CONSIDERED IN ORDER TO PREVENT BENDING, DISLOCATION, OR BREAKAGE OF THE IMPLANT DEVICE IN THE CASE OF DELAYED, MAL-UNION, OR NON-UNION OF BONE. IMMOBILIZATION SHOULD CONTINUE UNTIL A COMPLETE BONE FUSION MASS HAS DEVELOPED AND BEEN CONFIRMED.

    Additional Manufacturer Narrative · 0

    THE EXPLANT IS CURRENTLY BEING EVALUATED. A FOLLOW-UP REPORT WITH THE RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2024. APPROXIMATELY TWO AND A HALF MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGING REVEALED THAT THE ROD ON THE RIGHT SIDE OF THE CONSTRUCT HAD COMPLETELY DISENGAGED FROM THE TULIP HEAD, AND THE INTERBODY IMPLANT HAD ROTATED WITHIN THE DISC SPACE. DURING REVISION SURGERY, EXPOSURE OF THE ORIGINAL CONSTRUCT REVEALED ALL SET SCREWS WERE INTACT AND SECURE ON THE ROD EXCEPT FOR THE RIGHT L4 SCREW. ALTHOUGH THE SET SCREW REMAINED SEATED WITHIN THE TULIP HEAD, THE ROD HAD MIGRATED OUT OF POSITION. BOTH RODS WERE SUBSEQUENTLY REMOVED AND REPLACED, ALONG WITH THE SCREWS AT L4 AND L2. ALL SET SCREWS WERE ALSO REMOVED AND REPLACED. PRIOR TO FINAL TIGHTENING, THE INTERBODY IMPLANT WAS REPOSITIONED. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194914 INVICTUS SPINAL FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB ALPHATEC SPINE, INC. 15295-55-080 00190376269719

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention