BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORNERSTONE-SR CAGE SYSTEM

    MDR report key: 21665790 · Received March 21, 2025

    Report

    Report Number
    1030489-2025-01497
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    December 2, 2024
    Report Date
    March 21, 2025
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    ODP
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS #(B)(4):PART # 6272414; LOT # 51PR VISUAL AND OPTICAL INSPECTION CONFIRMED THE SPACER HAS BEEN DAMAGED DURING THE ADJUSTMENT PROCESS. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE PLACED ON THE SPACER DURING USE. G4: THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 2990826, 510K# K073291 AND UPN 00613994291035 IS APPROVED FOR THE US MARKET. 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 HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT USED IN THE ANTERIOR CERVICAL DISCECTOMY AND INTERBODY FUSION FOR CERVICAL DISC HERNIATION. IT WAS REPORTED THAT PRODUCT DAMAGE. EXPLANT COMPLETED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. THE PRODUCT WAS DAMAGED DURING INTRA OPERATIVE ADJUSTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545798 CORNERSTONE-SR CAGE SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, ODP MSD DEGGENDORF MFG 6272414 51PR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown