BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE® SPINAL SYSTEM

    MDR report key: 23120522 · Received September 23, 2025

    Report

    Report Number
    3003120897-2025-00278
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    June 27, 2025
    Report Date
    September 23, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MQP
    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

    E1: INITIAL REPORTER DETAILS ARE UNKNOWN G2: COUNTRY OF ORIGIN IS JAPAN H3: PRODUCT ANALYSIS: PART # 2990001; LOT # NM12A017 VISUAL AND OPTICAL INSPECTION CONFIRMED THE PRONGS AT THE TIP OF THE INSERTER HAVE BROKEN. THE DAMAGE TO THE TIP OF THE INSERTER IS CONSISTENT WITH 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR INTERBODY FUSION FOR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT WHEN THE CAGE WAS INSERTED AND TRIED TO CHANGE THE DIRECTION, THE TIP OF THE INSERTER CLAW PART WAS BROKEN.  THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206607 CAPSTONE® SPINAL SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC. 2990001 NM12A017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown