BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 23766733 · Received December 10, 2025

    Report

    Report Number
    1824199-2025-00096
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 19, 2025
    Report Date
    January 28, 2026
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    UDI-DI
    00673978042640
    PMA / PMN Number
    K982990
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PART # 811-300; LOT # 0532592W VISUAL AND FUNCTIONAL INSPECTION CONFIRMED THE SET SCREWS THAT WERE USED IN THE DOMINO ARE INCORRECT. 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

    E1: INITIAL REPORTER DETAILS ARE UNKNOWN G2: COUNTRY OF ORIGIN IS INDIA. 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 MANUFACTURER REPRESENTATIVE REGARDING A DEVICE FOR SPINAL THERAPY. IT WAS REPORTED THAT THE CROSS LINK WAS BROKEN DURING NON-CLINICAL OBSERVATION. THE PRODUCT WAS NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS DELIVERED AS DEFECTIVE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990546 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. 811-300 0532592W 00673978042640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown