BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEVO CERVICAL PLATE SYSTEM

    MDR report key: 21289948 · Received February 3, 2025

    Report

    Report Number
    1030489-2025-00520
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 13, 2024
    Report Date
    February 2, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    UDI-DI
    00643169342293
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. H3: PRODUCT ANALYSIS OF PART# 3030007 LOT# K23G1434 VISUAL AND OPTICAL EXAMINATION IDENTIFIED THAT THE TIP OF THE SCREWDRIVER IS WORN FROM WHAT APPEARS TO BE REPEATED NORMAL USE. THIS IS CONSISTENT WITH ANTICIPATED WEAR. H11: THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT WILL BE USED IN SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231370 ZEVO CERVICAL PLATE SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC 3030007 K23G1434 00643169342293

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown