BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION, INC

    MDR report key: 21274788 · Received January 30, 2025

    Report

    Report Number
    1723170-2025-00383
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 21, 2025
    Report Date
    March 12, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    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) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. CODES: B17, C20, D15 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

    H2, H3, H6) UPDATED INFORMATION IN SECTION D4. THE ACC 961-576 SURETRAK2, SMALL CLAMP WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS REPORTED THAT THE HEX HEAD ADJUSTMENT SCREW WAS SLIGHTLY DAMAGED BUT STILL RECEIVED DRIVERS WITHOUT ISSUE. THE CLAMP WAS VERY WORN BUT OTHERWISE FULLY FUNCTIONAL. CODES B01, C07, AND D02 ARE APPLICABLE. 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 INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SCREW HOLE WAS BROKEN. THERE WEAS NO SURGICAL DELAY. NO KNOWN IMPACT TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683562 MEDTRONIC NAVIGATION, INC ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 961-576 170214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...