BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVERSE SPINAL SYSTEM

    MDR report key: 24516102 · Received March 5, 2026

    Report

    Report Number
    3003200961-2026-00001
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 5, 2026
    Manufacturer
    CG MEDTECH CO., LTD.
    Product Code
    NKB
    UDI-DI
    08800247364765
    PMA / PMN Number
    K233960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A LITERATURE REVIEW INDICATES THAT, WHEN A SCREW IS DIRECTLY COUPLED TO THE MAIN ROD, A SMALLER ANGULATION BETWEEN THE SCREW HEAD AND SCREW BODY (SHAFT) MAY INCREASE LOAD CONCENTRATION AT THE SCREW NECK REGION (SOHN ET AL. 2018). BASED ON THE RECORD REVIEW AND AVAILABLE INFORMATION, NO MANUFACTURING ANOMALY WAS IDENTIFIED. THE EVENT IS THEREFORE PRESUMED TO HAVE RESULTED FROM A COMBINATION OF LOCALIZED LOADING AT THE SCREW NECK REGION ASSOCIATED WITH CONSTRUCT CONFIGURATION AND PATIENT-SPECIFIC CLINICAL FACTORS, INCLUDING A HIGHER LIKELIHOOD OF DELAYED UNION IN AN ELDERLY FEMALE PATIENT, LEADING TO PROGRESSIVE ACCUMULATION OF CYCLIC STRESS AND SUBSEQUENT FRACTURE. AS THIS IS THE FIRST SUCH CASE IDENTIFIED BY THE COMPANY, A DESIGN ENHANCEMENT IS UNDER EVALUATION TO REDUCE THE LIKELIHOOD OF RECURRENCE BY REINFORCING THE ILIAC SCREW NECK REGION. AS NO INTRINSIC QUALITY ISSUE WITH RELEASED PRODUCT HAS BEEN IDENTIFIED, THE COMPANY WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS AND ASSESS TREND INFORMATION.

    Description of Event or Problem · 0

    INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025. DURING FOLLOW-UP EVALUATION, AN X-RAY TAKEN AROUND (B)(6) 2026 IDENTIFIED A FRACTURE AT THE NECK REGION OF THE ILIAC SCREW IMPLANTED AT THE S2 LEVEL. A REVISION SURGERY WAS PERFORMED ON(B)(6) 2026 TO REMOVE THE FRACTURED SCREW, AND THE IMPLANT WAS REPLACED. THE FRACTURED DEVICE WAS RETRIEVED, AND THE MANUFACTURING AND INSPECTION RECORDS FOR THE ASSOCIATED LOT WERE REVIEWED. THE INVOLVED DEVICE WAS POLYAXIAL STD. SCREW (QUAD) -8.5X70 MM (LOT NO. 24K22130). REVIEW OF MANUFACTURING AND INSPECTION RECORDS CONFIRMED THAT COMPLIANT RAW MATERIAL WITHIN THE REQUIRED CHEMICAL COMPOSITION AND MECHANICAL PROPERTY SPECIFICATIONS WAS USED, AND THAT THE DEVICE GEOMETRY, DIMENSIONS, AND VISUAL APPEARANCE MET APPLICABLE SPECIFICATIONS. THE DEVICE WAS DESIGNED TO MEET ASTM F1717 REQUIREMENTS CONSIDERING CLINICALLY RELEVANT LOADING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580294 INNOVERSE SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW NKB CG MEDTECH CO., LTD. NPA8570PSQ 24K22130 08800247364765

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization| R