BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE SPINAL SYSTEM

    MDR report key: 20298181 · Received September 25, 2024

    Report

    Report Number
    1030489-2024-01193
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    June 25, 2024
    Report Date
    September 25, 2024
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MAX
    UDI-DI
    00643169430679
    PMA / PMN Number
    K172199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THE COUNTRY OF THE EVENT IS AUSTRALIA. H3. DEVICE EVALUATION SUMMARY: PRODUCT ANALYSIS #(B)(6): PART # 7771023 LOT # 0737333W. VISUAL AND OPTICAL INSPECTION CONFIRMED THE SCREW THAT ELEVATES AND COLLAPSES THE IMPLANT HAS BEEN BACKED OUT PAST ITS LIMIT. THE IMPLANT IS NO LONGER FUNCTIONAL DUE TO THE SCREW BEING BACKED OUT. 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 A PATIENT HAVING L4-S1 MINIMALLY INVASIVE ROBOTIC TLIF FOR AN INDICATION OF L4/S1 DEGENERATION. IT WAS REPORTED THAT THE INSERTER TIP BROKE OFF DURING INSERTION OF CAGE AND THERE WAS ONLY ONE INSERTER ON THE SET, THEREFORE THE CAGE THEN HAD TO BE PULLED OUT AND NOT USED AS IT WAS NOT INSERTED COMPLETELY WHEN IT BROKE. THE SURGEON HAD TO USE ANOTHER TYPE OF CAGE THE HOSPITAL HAD ON SHELF. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234155 ELEVATE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX WARSAW ORTHOPEDICS 7771023 0737333W 00643169430679

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male