BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE® SPINAL SYSTEM

    MDR report key: 22607315 · Received July 25, 2025

    Report

    Report Number
    1030489-2025-02499
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    May 12, 2025
    Report Date
    July 25, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MQP
    UDI-DI
    00613994803061
    PMA / PMN Number
    K103731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3:PRODUCT ANALYSIS # (B)(4):PART # 2990001, LOT # KH19H114 VISUAL AND OPTICAL INSPECTION CONFIRMED ONE OF THE PRONGS OF THE INSERTER HAS BROKEN. THE DAMAGE TO THE TIP OF THE INSERTER IS CONSISTENT WITH BEND STRESS OVERLOAD. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A INSERTER USED FOR SPIN AL THERAPY. IT WAS REPORTED THAT ONE OF THE CLIPS THAT MATES WITH THE IMPLANT WAS MISSING FROM THE BASE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286004 CAPSTONE® SPINAL SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC 2990001 KH19H114 00613994803061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown