BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 24361502 · Received February 17, 2026

    Report

    Report Number
    1824199-2026-00022
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Report Date
    April 3, 2026
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    MJO
    UDI-DI
    00613994714831
    PMA / PMN Number
    P090029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PRODUCT:6973050, LOT:EM17H003 VISUAL AND OPTICAL INSPECTION CONFIRMED THE INNER SHAFT INSERTER IS WORN FROM REPEATED USE. 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.

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS UNKNOWN D4: LOT NUMBER IS UNKNOWN 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE ACTUAL ALLEGATION WAS THE BENT RAIL CUTTER WILL NOT CUT STRAIGHT AND BENT INSERTER WILL NOT INSERT.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR CERVICAL ARTHROPLASTY P ROCEDURE. IT WAS REPORTED THAT THERE WAS A LOSS OF ELASTICITY IN THE INSERTER SHAFT, RESULTING IN INABILITY TO GRAB THE IMPLANT, AND SLIGHT DAMAGE TO ONE OF THE BLADES OF THE RAIL PUNCH, CAUSING ISSUES WHEN CREATING KEELS IN THE VERTEBRAE. INSTRUMENT BREAKAGE WAS IDENTIFIED FOR BOTH THE INSERTER SHAFT AND RAIL PUNCH. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423117 PRESTIGE CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDIC, INC. 6973050 EM17H003 00613994714831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown