BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE PTC¿ SPINAL SYSTEM

    MDR report key: 23107344 · Received September 22, 2025

    Report

    Report Number
    3011795235-2025-00014
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    July 10, 2025
    Report Date
    September 22, 2025
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    K172199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART # 3992609, LOT # 47RN - VISUAL AND OPTICAL INSPECTION CONFIRMED THE INNER THREADS OF THE SPACER APPEAR TO BE DAMAGED FROM MISALIGNMENT. 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 (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A DEVICE USED FOR MINIMALLY INVASIVE TRA NSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE INTERNAL THREAD OF THREADED INSERTER COULD NOT ENGAGE WITH THE CAGE HOLE. THE INNER THREAD KEPT SPINNING FREELY. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, THE CAGE WITH REPLACED WITH ANOTHER CAGE OF THE SAME SIZE. THE NEW CAGE WAS SUCCESSFULLY ATTACHED AND IMPLANTED. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026429 CAPSTONE PTC¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MSD DEGGENDORF MFG 3992609 47RN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown