BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE(TM) CERVICAL DISC SYSTEM

    MDR report key: 23861730 · Received December 22, 2025

    Report

    Report Number
    3003120897-2025-00768
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Report Date
    December 22, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MJO
    PMA / PMN Number
    SEE H11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 6961460, PMA #P060018, UDI: (B)(4) WAS CLEARED IN THE UNITED STATES. 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 SPINAL THERAPY. IT WAS REPORTED THAT, THERE WAS FRACTURE OF THE RIGHT C3 SCREW AND CRACKING OF THE CRANIAL IMPLANT AT C5/6 TOTAL DISC REPLACEMENT. THERE WAS PROGRESSION OF POSTOPERATIVE KYPHOSIS AND IMPLANT DAMAGE REQUIRED REOPERATION. NECK PAIN OCCURRED, BUT NO NEUROLOGICAL SYMPTOMS WERE PRESENT. ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2025. PROCEDURE PERFORMED WAS POSTERIOR DECOMPRESSION FUSION AT C3/6 PERFORMED USING INFINITY. NO PLAN TO PERFORM REVISION SURGERY TO EXPLANT THE BROKEN PRODUCTS. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571916 PRESTIGE(TM) CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO MEDTRONIC SOFAMOR DANEK USA, INC. 6971650 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention