BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE PTC¿ SPINAL SYSTEM

    MDR report key: 21332011 · Received February 7, 2025

    Report

    Report Number
    1030489-2025-00630
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    November 4, 2024
    Report Date
    February 7, 2025
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    UDI-DI
    00643169187412
    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# 3992611, LOT# 59PU - OPTICAL AND MICROSCOPIC EXAMINATION OF THE IMPLANT RETURNED FOR ANALYSIS IDENTIFIED DEFORMATION AT THE INSERTER MATING FACE AND THREADS ARE DAMAGED. THIS IS CONSISTENT WITH SIGNIFICANT IMPACT DURING ATTEMPTED IMPLANTATION. 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. 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 PATIENT HAVING MINIMALLY INVASIVE TRAN SFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF). IT WAS REPORTED THAT THE INNER THREAD OF INSERTER WAS IDLE AND THE INSERTER CANNOT MOVE FORWARD AND ATTACH THE CAGE. A NEW SAME SIZE CAGE WAS OPENED AND ATTACHED SUCCESSFULLY. 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
    701194 CAPSTONE PTC¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MSD DEGGENDORF MFG 3992611 59PU 00643169187412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female