BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVICTUS¿ OCT SPINAL FIXATION SYSTEM

    MDR report key: 15725731 · Received November 4, 2022

    Report

    Report Number
    2027467-2022-00081
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 4, 2022
    Report Date
    October 4, 2022
    Manufacturer
    ALPHATEC SPINE
    Product Code
    NKG
    UDI-DI
    00190376303758
    PMA / PMN Number
    K203125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D5. HEALTH PROFESSIONAL H6. TYPE OF INVESTIGATION: 3331, 10, 4102 INVESTIGATION FINDINGS: 3243 INVESTIGATION CONCLUSION: 19, 61 H10. THE IMPLANT WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. A REVIEW OF THE DHR INDICATED NO REMARKABLE MANUFACTURING OR QUALITY ITEMS THAT WOULD HAVE IMPACTED PERFORMANCE RELATIVE TO THE COMPLAINT BEYOND THE INTENDED DESIGN. THERE ARE NO INDICATIONS THAT THE DESIGN, MANUFACTURING, OR INITIAL QUALITY OF THE IMPLANT CONTRIBUTED TO THE COMPLAINT. QTY 82 OF PN 19000-55-40LN TO00812 WERE MANUFACTURED TO DRAWING REV B AND RELEASED INTO INVENTORY ON 05/03/2022. THE INVICTUS OCT POLYAXIAL SCREW PN 19000-55-40 WAS VISUALLY AND PHYSICALLY EXAMINED UPON RECEIPT AND SHOWED NO APPARENT SIGNS OF MANUFACTURING DEFECT. THE SCREW WAS RECEIVED NOT INTACT AND RETURNED WITH A SHANK FACTURE AT THE NECK OF THE SCREW. ADDITIONAL DAMAGE AND MARKINGS TO THE SCREW WERE OBSERVED AND ARE ATTRIBUTED TO THE REMOVAL AND RETRIEVAL OF THE IMPLANT DURING THE SURGERY. THE RETURNED IMPLANT SHANK CLEARLY INDICATES A FRACTURE AT THE NECK MOST LIKELY DUE TO EXCESS TORSIONAL LOAD. THE FOLLOWING TESTING AND CHARACTERIZATION DATA FOR THIS DESIGN IS SUMMARIZED BELOW FOR AN EVALUATED 4.5MM SCREW IN COMPARISON TO THE RETURNED 5.5MM SCREW WHICH SHARE THE SAME NECK DIAMETER OF .109" (2.77MM). · 4.5MM SCREWS WERE TORQUED TO FAILURE IN A VISE AS WELL AS INSERTED INTO 40 AND 50 PCF BONE FOAM IN ORDER TO COMPARE TO THE COMPLAINT FAILURES. RESULTS AND IMAGES ARE CAPTURED IN THE TABLES BELOW. · THE 19000-45-40 FAILURES EXHIBITED SIMILAR WITNESS MARKS AS THOSE SEEN IN THE INVESTIGATION IMPLANT FOR BOTH STRICT TORSIONAL FAILURES & LATERAL BENDING FAILURES. THE PATIENT'S BONE QUALITY IS UNKNOWN; HOWEVER, THE FAILURE CODE BE A RESULT OF THE PATIENT HAVING UNCHARACTERISTICALLY DENSE BONE CREATING A VERY HIGH INSERTION TORQUE. THE SCREW COULD ALSO HAVE EXPERIENCED LATERAL BENDING DURING INSERTION ADDING TO THE INCREASED LOADING CONDITION. THE ROOT CAUSE IS A RESULT OF THE TORSIONAL LOAD EXPERIENCED EXCEEDED THE DESIGN LIMITATIONS FOR THE SHANK AND DESIGN TESTED AND APPROVED. LABELING REVIEW: WARNING/CAUTIONS: "BASED ON THE FATIGUE TEST RESULTS, THE PHYSICIAN/SURGEON SHOULD CONSIDER THE LEVELS OF IMPLANTATION, PATIENT WEIGHT, PATIENT ACTIVITY LEVEL AND PATIENT CONDITIONS, WHICH MAY IMPACT THE PERFORMANCE OF THE SYSTEM WHEN USING THIS DEVICE. USE OF THESE SYSTEMS IS SIGNIFICANTLY AFFECTED BY THE SURGEON'S PROPER PATIENT SELECTION, PREOPERATIVE PLANNING, PROPER SURGICAL TECHNIQUE, PROPER SELECTION AND PLACEMENT OF IMPLANTS. NO SPINAL IMPLANT CAN WITHSTAND BODY LOADS FOR AN INDEFINITE PERIOD OF TIME WITHOUT THE SUPPORT OF BONE. IN THE EVENT THAT SUCCESSFUL FUSION IS NOT ACHIEVED, BENDING, BREAKAGE, LOOSENING, OR DISASSEMBLY OF THE DEVICE WILL OCCUR. 11. 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: THE FOLLOWING COMPLICATIONS AND ADVERSE REACTIONS HAVE BEEN SHOWN TO OCCUR WITH THE USE OF SIMILAR SPINAL INSTRUMENTATION. THESE EFFECTS AND ANY OTHER KNOWN BY THE SURGEON MUST BE DISCUSSED WITH THE PATIENT PREOPERATIVELY. 1. INITIAL OR DELAYED LOOSENING, DISASSEMBLY, BENDING, DISLOCATION AND/OR BREAKAGE OF DEVICE COMPONENTS."

    Additional Manufacturer Narrative · 0

    THE IMPLANT 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

    WHEN THE SURGEON WAS IMPLANTING THE SCREW, HE FELT RESISTANCE ABOUT ¾ OF THE WAY AND DECIDED TO BACK THE SCREW OUT. WHILE BACKING THE SCREW OUT, THE TULIP HEAD SNAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2816028 INVICTUS¿ OCT SPINAL FIXATION SYSTEM POSTERIOR CERVICAL SCREW SYSTEM NKG ALPHATEC SPINE 19000-55-40 TO00812 00190376303758

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male