BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC STEREOTAXIC INSTRUMENT

    MDR report key: 19182267 · Received April 25, 2024

    Report

    Report Number
    1723170-2024-01149
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    April 2, 2024
    Report Date
    May 17, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    PMA / PMN Number
    K131425
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE INSTRUMENT, PRODUCT ID: 9733236, LOT NUMBER: 230913, WAS RETURNED AND ANALYSIS CONFIRMED THE REPORTED EVENT. THE CROSS PIN HAD BEEN BROKEN OFF OR PUSHED INTO THE PERCUTANEOUS (PERC) PIN. THE TIP OF THE PERC PIN HAD BEEN SEVERELY TWISTED AND BROKEN OFF. 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.

    Additional Manufacturer Narrative · 0

    H3/H6: THE DEVICE HAS BEEN RETURNED AND IS PENDING ANALYSIS. CODES B21, C21, AND D16 APPLY. 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 AT THE END OF THE CASE WHEN REMOVING THE PERC PIN (150MM), THE CROSS PIN THAT THE SLAP HAMMER HOOKS ONTO VIA THE J-HOOK FIRST BROKE OFF. THEN WHEN TRYING TO JUST PULL THE REST OF THE PIN OUT OF THE PATIENT, IT BROKE OFF.  THERE WAS A 3 MINUTE DELAY WHILE THE SURGEON ATTEMPTED TO REMOVE THE DISTAL END OF THE PIN, HOWEVER, OPTED TO JUST LEAVE IT IN THE PATIENT. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614628 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9733236 230913

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Other