BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE SPINAL SYSTEM

    MDR report key: 21580440 · Received March 11, 2025

    Report

    Report Number
    1030489-2025-01291
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    July 29, 2022
    Report Date
    March 11, 2025
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MAX
    UDI-DI
    00643169430815
    PMA / PMN Number
    K172199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PRODUCT ID# 8880828; LOT# 0721420W 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 FROM A USER FACILITY(UF) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE LOCKING SCREW AT THE DISTAL END OF THE IMPLANT WAS STRIPPED, THE IMPLANT COULD NOT EXPAND AND TIGHTEN. THERE WAS NO PATIENT INVOLVEMENT IN THE EVENT AND NO FURTHER COMPLICATIONS/SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE DISTAL END OF THE DRIVER WAS WORN DOWN SO IT WOULDN'T PROPERLY ENGAGE WITH ANY UNIVERSAL HANDLE THAT WE WOULD TRY TO PAIR IT WITH AND THE LOCKING MECHANISM ON BOTH DRIVERS WOULD NOT STAY LOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416198 ELEVATE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX WARSAW ORTHOPEDICS 8880828 0721420W 00643169430815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown