BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 22881848 · Received August 25, 2025

    Report

    Report Number
    1824199-2025-00016
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    June 4, 2025
    Report Date
    August 25, 2025
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    MJO
    UDI-DI
    00613994714824
    PMA / PMN Number
    P090029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. DEVICE EVALUATION SUMMARY: PRODUCT ANALYSIS # (B)(4): PART # 6973000, LOT # EM19J029. VISUAL AND OPTICAL INSPECTION CONFIRMED THE TIP OF THE INSERTER HANDLE IS CRACKED. THE DAMAGE IS CONSISTENT WITH OVERLOAD AS THE MECHANISM OF FAILURE. 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 VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR CERVICAL DISC ARTHROPLASTY. IT WAS REPORTED THAT THE PART OF THE INSTRUMENT THAT HOLDS THE IMPLANT WAS CRACKED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291588 PRESTIGE CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDIC, INC. 6973000 EM19J029 00613994714824

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown