BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATED CD HORIZON SOLERA PIN

    MDR report key: 19843248 · Received July 26, 2024

    Report

    Report Number
    1723170-2024-01821
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 5, 2024
    Report Date
    August 29, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K131425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3) NO PARTS HAVE BEEN RETURNED FOR 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.

    Additional Manufacturer Narrative · 0

    H3, H6: ANALYSIS WAS PERFORMED FOR PRODUCT: 9733235, LOT NUMBER: 231219. THERE WAS DAMAGE NOTED ON THE THE TIP OF THE PIN, BUT THE FIT ISSUE DID NOT SEEM TO BE CAUSED BY THE PIN IN QUESTION. 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 DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERC PIN WAS TOO THICK TO FIT IN THE RECEIVER OF THE PERC PIN FRAME. THEY TRIED ATTACHING THE ADAPTER TO THE J-HOOK BEFORE IMPLANTING THE PERC PIN IN THE PATIENT TO DISCOVER THE NON-COMPLIANCE BEFORE FORCEFULLY ATTACHING IT TO THE PERC PIN. THERE WAS NO REPORTED DELAY TO PROCEDURE AND NO REPORTED IMPACT TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877949 NAVIGATED CD HORIZON SOLERA PIN ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 9733235 231219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown