BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE® SPINAL SYSTEM

    MDR report key: 23919247 · Received December 29, 2025

    Report

    Report Number
    3003120897-2025-00818
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    October 22, 2025
    Report Date
    December 29, 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

    G2: COUNTRY OF ORIGIN IS JAPAN. H3: PRODUCT ANALYSIS # (B)(4). PART # 2990001, LOT # NM12F025 VISUAL AND OPTICAL INSPECTION CONFIRMED ONE OF THE PRONGS AT THE TIP OF THE INSERTER IS BROKEN. THE DAMAGE TO THE INSTRUMENT 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 TRANSFORAMINAL LUMBAR INTERBODY SPINAL THERAPY FOR L4 DEGENERATIVE SPONDYLOLISTHESIS TO L4/5 LEVELS. IT WAS REPORTED THAT AN AA 24×10 MM CAGE WAS INSERTED AT L4/5. AFTER REMOVING THE INSERTER, A SLIGHT INWARD TILT OF THE CAGE WAS REQUESTED. THE INSERTER WAS REINTRODUCED INTO THE DISC SPACE, AND THE INNER SHAFT WAS ROTATED SEVERAL TIMES TO ADJUST. A ¿CLICK¿ WAS HEARD, AND UPON REMOVAL, ONE TINE OF THE BIFURCATED INSERTER TIP WAS MISSING. THE FRAGMENT WAS RETRIEVED FROM THE BODY USING A PUNCH AND FORCEPS IN APPROXIMATELY 2 MINUTES. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE ARE SIGNS OF WEAR ON THE THREADS APPROXIMATELY 2.3 CM FROM THE HEAD FOR PLI 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197338 CAPSTONE® SPINAL SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC. 2990001 NM12F025 00613994803061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown