BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE SPINAL SYSTEM

    MDR report key: 23345631 · Received October 21, 2025

    Report

    Report Number
    1824199-2025-00068
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 25, 2025
    Report Date
    December 15, 2025
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    MAX
    UDI-DI
    00643169430433
    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

    ADDITIONAL INFORMATION: D9, H3, H6 H3. DEVICE EVALUATION SUMMARY: PRODUCT ANALYSIS #834641613: 7770723 LOT# 1044431W VISUAL AND OPTICAL EXAMINATION REVIEW CONFIRMS IMPLANT FRACTURE. WITNESS MARKS AND MATERIAL DEFORMATION NOTED ON THE THRU HOLE OF THE PEEK ANTERIOR RAMP. THESE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD OF THE IMPLANT. 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

    G2: THE COUNTRY OF THE EVENT IS TAIWAN. 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 MANUFACTURER REPRESENTATIVE VIA A HEALTHCARE PROFESSIONAL REGARDING A PATIENT HAVING MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF) FOR AN INDICATION OF L5-S1 HERNIATED INTERVERTEBRAL DISC. IT WAS REPORTED THAT AFTER SIZING WITH TRIAL INSTRUMENTS, THE SELECTED IMPLANT WAS INSERTED, AND A LOOSE TACTILE SENSATION WAS NOTED PRIOR TO EXPANSION. THE IMPLANT WAS REMOVED FOR INSPECTION AND WAS FOUND TO HAVE A FRACTURED SURFACE ON THE PEEK MATERIAL. THE IMPLANT WAS IMMEDIATELY REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS SAFELY AND SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451789 ELEVATE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX WARSAW ORTHOPEDIC, INC. 7770723 1044431W 00643169430433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female