BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE¿ SPINAL SYSTEM

    MDR report key: 21527726 · Received March 5, 2025

    Report

    Report Number
    1030489-2025-01177
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    November 10, 2022
    Report Date
    March 5, 2025
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MAX
    UDI-DI
    00643169430433
    PMA / PMN Number
    K172199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS #(B)(4);PRODUCT:7770723 ; LOT# 0883964W VISUAL AND OPTICAL EXAMINATION REVIEW CONFIRMS IMPLANT THREADS DAMAGED. WITNESS MARKS AND MATERIAL DEFORMATION NOTED ON THE THRU HOLE OF THE PEEK ANTERIOR RAMP. THESE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD OF 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 FORM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT CAGE WOULD NOT COLLAPSE. NO PATIENT INVOLVED IN THIS EVENT. ADDITIONAL UPDATE RECEIVED TLIF PROCEDURE USED AND PRODUCT NOT CAME IN CONTACT WITH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479929 ELEVATE¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX WARSAW ORTHOPEDICS 7770723 0883964W 00643169430433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown