BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON¿ TAS INTERBODY SYSTEM

    MDR report key: 21066194 · Received January 3, 2025

    Report

    Report Number
    1030489-2025-00057
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    July 18, 2023
    Report Date
    January 3, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HWJ
    UDI-DI
    00191375001898
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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# 2300-1035 LOT# Y170838 VISUAL AND OPTICAL EXAMINATION IDENTIFIED THAT THE TIPS OF THE AWLS ARE DULL FROM WHAT APPEARS TO BE FROM REPEATED NORMAL USE AND AUTOCLAVING. 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 VIA A MANUFACTURER REPRESENTATIVE REGARDING THE INSTRUMENTS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE WORN AND BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457374 ENDOSKELETON¿ TAS INTERBODY SYSTEM AWL HWJ MEDTRONIC SOFAMOR DANEK USA, INC 2300-1035 Y170838 00191375001898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown