BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC STEREOTAXIC INSTRUMENT

    MDR report key: 23659257 · Received November 26, 2025

    Report

    Report Number
    1723170-2025-03820
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 26, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    UDI-DI
    00721902467738
    PMA / PMN Number
    K983670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: ANALYSIS WAS PERFORMED FOR PRODUCT: 961-576, LOT NUMBER: 160707. IT WAS REPORTED THAT THE ADJUSTMENT SCREW HAD BEEN CROSS THREADED AND HAS NOW SEIZED. CODES B01, C07 AND D02 ARE APPLICABLE TO THIS ANALYSIS. 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

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED PRE-OPERATIVELY OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE FIXATION SCREW CAME OFF DURING PRE-USAGE PREPARATION, SO IT COULD NOT BE FIXATED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2672207 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 961-576 160707 00721902467738

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown