BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE(TM) CERVICAL DISC SYSTEM

    MDR report key: 22963225 · Received September 4, 2025

    Report

    Report Number
    1824199-2025-00035
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 8, 2025
    Report Date
    September 4, 2025
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    MJO
    UDI-DI
    00885074236087
    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

    G2: COUNTRY OF EVENT: JAPAN. 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 IMPLANTED WITH PRESTIGE DISC HAVING TOTAL DISC REPLACEMENT (TDR) THERAPY FOR CERVICAL DISC HERNIATION AND CERVICAL MYELOPATHY. IT WAS REPORTED THAT THE BONE WAS HARD, AND THE RAIL PUNCH COULD NOT BE FULLY INSERTED DURING RAIL CREATION. DURING IMPLANT INSERTION, SIGNIFICANT FORCE WAS APPLIED TO DRIVE IT IN, AND IT WAS SOMEHOW MANAGED TO REACH THE PROPER POSITION. THE PROCEDURE WAS COMPLETED ON THE DAY, BUT DISLOCATION WAS DISCOVERED LATER ON CT SCAN. POSTOPERATIVE AXIAL IMAGES CONFIRMED THAT THE IMPLANT PLACEMENT DURING THE INITIAL SURGERY WAS SIGNIFICANTLY LEFTWARD. THEREFORE, THE RAIL WAS RE-CUT MORE TO THE LEFT (CAREFULLY ENSURING THAT THE NEW RAIL DID NOT OVERLAP WITH THE EXISTING TRAJECTORY), AND THE IMPLANT WAS REINSERTED. THE IMPLANT USED WAS THE SAME ONE FROM THE INITIAL INSERTION. ALTHOUGH THE DOCTOR WAS INFORMED THAT REPOSITIONING THE IMPLANT WAS CONTRAINDICATED, IT WAS CHOSEN AFTER THOROUGHLY CONFIRMING THAT THERE WAS NO DAMAGE TO THE IMPLANT. THE BONE WAS HARD, SO THE RAIL PUNCH COULD NOT BE CUT TO THE POSITION SPECIFIED IN THE PROCEDURAL MANUAL. LEVELS IMPLANTED WAS C5/6. THERE WERE NO COMPLICATIONS OR ANY SYMPTOMS OCCURRED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331320 PRESTIGE(TM) CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDIC, INC. 6971660 0999196W 00885074236087

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention