BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON¿ TAS INTERBODY SYSTEM

    MDR report key: 21113294 · Received January 9, 2025

    Report

    Report Number
    3006340236-2025-00005
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    March 13, 2024
    Report Date
    January 9, 2025
    Manufacturer
    TITAN SPINE
    Product Code
    HWJ
    UDI-DI
    00191375001942
    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: (B)(4), LOT# Y160803 VISUAL AND OPTICAL EXAMINATION REVEALED THE TIP OF THE INSTRUMENT IS BENT FROM WHAT APPEARS TO BE OVERLOAD. THIS IS CONSISTENT WITH BEND STRESS OVERLOAD. 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 AN INSTRUMENT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324328 ENDOSKELETON¿ TAS INTERBODY SYSTEM AWL HWJ TITAN SPINE 2300-1110 Y160803 00191375001942

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown