BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVICTUS

    MDR report key: 20751556 · Received November 21, 2024

    Report

    Report Number
    2027467-2024-00154
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    October 24, 2024
    Report Date
    November 21, 2024
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    NKB
    UDI-DI
    00190376137902
    PMA / PMN Number
    K181677
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: H3. YES. H6. INVESTIGATION FINDINGS: 3243. INVESTIGATION CONCLUSIONS: 61. ADDITIONAL INFORMATION: D4. MODEL #: 55475-090-070. CATALOG #: 55475-090-070. LOT #: AP01939. PRIMARY UDI: (B)(4). G4. 510(K): K214006. H4. 03/25/2024. DEVICE EVALUATION: VISUAL INSPECTION OF THE SET SCREW SHOWED CHATTERING WEAR MARKS AROUND THE CIRCUMFERENCE, WHEREAS TYPICAL SET SCREW WEAR HAS AN EVEN HOURGLASS WEAR PATTERN ON THE UNDERSIDE. THESE WEAR MARKS INDICATE EXCESSIVE OR UNINTEND MOTION IN THE ROD-SCREW CONSTRUCT WHICH IS CONSISTENT WITH THE SET SCREW BACKOUT DESCRIPTION OF INCIDENT. ADDITONALLY, DEFORMATION TO THE MAX CRANIAL-CAUDAL FLAT OF THE CLOSED FIXED-ANGLE TULIP INDICATES THAT THE SHANK WAS AT MAX ANGULATION WHICH COULD CONTRIBUTE TO IMPROPER ROD LOCKDOWN/NORMALIZATION. WITH MINIMAL TO NO ADDITIONAL MOVMENT LEFT BETWEEN THE TULIP AND THE SHANK OF THE SCREW, CONSTRUCTS AT THE MAX ANGLE MAY BE MORE DIFFICULT TO NORMALIZE TO THE ROD AND SEAT PROPERLY. WEAR TO THE BUSHING ROD SLOT CAN ALSO BE SEEN FURTHER INDICATING EXCESSIVE OR UNINTENDED MOTION IN THE ROD-SCREW CONSTRUCT. REVIEW OF DEVICE HISTORY RECORDS 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.

    Description of Event or Problem · 0

    AROUND 2-WEEKS POSTOPERATIVELY FROM AN INITIAL REVISION SURGERY, RADIOGRAPH IMAGES CONFIRMED THE SET SCREW BACKED OUT OF THE SCREW ON THE LEFT SIDE OF THE CONSTRUCT AT L5. REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE SET SCREW AND SCREW. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236033 INVICTUS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB ALPHATEC SPINE, INC. 15100 SM182008 00190376137902

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention