BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE¿ SPINAL SYSTEM

    MDR report key: 21065169 · Received January 3, 2025

    Report

    Report Number
    1030489-2025-00039
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    March 22, 2023
    Report Date
    January 3, 2025
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MAX
    UDI-DI
    00643169430433
    PMA / PMN Number
    K172199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PRODUCT:7770723, LOTNO:0899475W - VISUAL AND OPTICAL INSPECTION REVEALED BOTH TABS/EARS OF THE IMPLANT HAS BEEN BROKEN OFF. THERE IS NO DAMAGE PRESENT ON THE NOSE OF THE IMPLANT. IT APPEARS THE CAGE HAS BROKEN DUE TO EXCESSIVE FORCE PLACED ON THE IMPLANT. 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT BEFORE INSERTING THE CORRESPONDING CAGE, THE DEVICE WAS FOUND TO BE BROKEN DURING THE OPERATION CHECK OF THE EV. THE DETAILS OF THE BREAKAGE ARE UNKNOWN. THE PATIENT WAS ON THE OPERATION TABLE WHEN THE PRODUCT PROBLEM WAS IDENTIFIED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116770 ELEVATE¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX WARSAW ORTHOPEDICS 7770723 0899475W 00643169430433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown