BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL MIS PEDICLE SCREW SYSTEM

    MDR report key: 24431549 · Received February 24, 2026

    Report

    Report Number
    MW5184339
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    June 25, 2024
    Report Date
    February 18, 2026
    Manufacturer
    HIGHRIDGE MEDICAL, LLC
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I UNDERWENT SPINAL FUSION ON (B)(6) 2024, DURING WHICH A VITAL MIS PEDICLE SCREW SYSTEM (ZIMVIE) WAS IMPLANTED. APPROXIMATELY THREE WEEKS POST-OPERATIVELY, I DEVELOPED SYMPTOMS AND WAS DIAGNOSED WITH MYCOBACTERIUM ABSCESSUS INFECTION. ON (B)(6) 2025, HARDWARE REMOVAL WAS PERFORMED. INTRAOPERATIVE CULTURES TAKEN DIRECTLY FROM THE LEFT L5 PEDICLE SCREW HOLE WERE POSITIVE FOR MYCOBACTERIUM ABSCESSUS. THE INFECTION REQUIRED MULTIPLE SURGICAL DEBRIDEMENTS, PROLONGED IV ANTIBIOTIC THERAPY VIA PICC LINE, AND EXTENDED ORAL ANTIBIOTIC TREATMENT. I REMAIN ON MEDICAL DISABILITY. MYCOBACTERIUM ABSCESSUS IS AN UNCOMMON PATHOGEN IN SPINAL FUSION PROCEDURES. GIVEN THE CONFIRMED INFECTION AT THE PEDICLE SCREW SITE, I AM REQUESTING REVIEW FOR POTENTIAL DEVICE CONTAMINATION, STERILIZATION BREACH, MANUFACTURING DEFECT, OR BATCH-RELATED ISSUE INVOLVING THE VITAL MIS PEDICLE SCREW SYSTEM. CULTURE OBTAINED INTRAOPERATIVELY FROM LEFT L5 PEDICLE SCREW HOLE DURING HARDWARE REMOVAL SURGERY. RESULT POSITIVE FOR MYCOBACTERIUM ABSCESSUS. INFECTION INVOLVED IMPLANTED PEDICLE SCREW SYSTEM (VITAL MIS ¿ ZIMVIE). HARDWARE REMOVAL REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499711 VITAL MIS PEDICLE SCREW SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB HIGHRIDGE MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention| S| H| L 8 NEW SCREWS IMPLANTED ON (B)(6) 2025.| LYRICA 100MG.| OXYCONTIN 10MG.| PERCOCET 7.5-325.