BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE¿ SPINAL SYSTEM

    MDR report key: 22051910 · Received May 20, 2025

    Report

    Report Number
    1030489-2025-02029
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    April 25, 2025
    Report Date
    July 8, 2025
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MAX
    UDI-DI
    00643169430778
    PMA / PMN Number
    K172199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS #(B)(4): PRODUCT ID: 8880823 LOT# 1011271W. VISUAL AND MICROSCOPIC INSPECTION CONFIRMED THE PEEK PORTION OF THE SPACER HAS BROKEN AWAY FROM THE SPACER. THERE ARE WITNESS MARKS ON THE BACKSIDE OF THE SPACER INDICATING THAT THE SPACER WAS IMPACTED. BOTH OF THE EARS ON THE PEEK PORTION OF THE SPACER HAVE BROKEN OFF INDICATING THAT THE IMPLANT CAME IN CONTACT WITH BONE AND WAS PUSHED BACK, CAUSING THE EARS TO BREAK OFF AND THAT SECTION OF THE IMPLANT TO SEPARATE. THIS TYPE OF DAMAGE IS CONSISTENT WITH OVERLOAD. 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 HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERWENT MIS-TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) SURGERY. IT WAS REPORTED THAT CAGE WAS BROKEN. REPLACED THE NEW ONE CAGE AND FINISHED THE SURGERY. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166588 ELEVATE¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX WARSAW ORTHOPEDICS 8880823 1011271W 00643169430778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female