BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON¿ TAS INTERBODY SYSTEM

    MDR report key: 21032995 · Received December 30, 2024

    Report

    Report Number
    1030489-2024-01814
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    July 18, 2023
    Report Date
    December 30, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    UDI-DI
    00191375001881
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PART# 2300-1034, LOT# Y171152 VISUAL AND FUNCTIONAL TESTING IDENTIFIED THAT THE TIP OF THE INSTRUMENT 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 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
    2435618 ENDOSKELETON¿ TAS INTERBODY SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC 2300-1034 Y171152 00191375001881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown