BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURETRAK¿ II UNIVERSAL TRACKER, LARGE PASSIVE FIGHTER

    MDR report key: 19373829 · Received May 22, 2024

    Report

    Report Number
    1723170-2024-01335
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 16, 2024
    Report Date
    July 19, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    UDI-DI
    00721902467684
    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

    H2) CORRECTION MADE TO ANNEX A CODE. ANNEX A HAS BEEN CORRECTED FROM A05 TO A0709. 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

    H6) THE PRODUCT: 961-581, LOT NUMBER: 150728, RETURNED TO THE MANUFACTURER AND ANALYSIS CONFIRMED THE REPORTED EVENT. THE RETURNED INSTRUMENT WAS SEVERELY BENT AND THE TRACKER WAS NOT USABLE AS IT WAS. CODES B01, C07, C13, AND D02 ARE APPLICABLE TO THIS RETURNED PRODUCT ANALYSIS. A1-5: SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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) ADDITIONAL INFORMATION IN SECTION B5. H2) DUE TO ADDITIONAL INFORMATION PROVIDED, ANNEX A HAS BEEN UPDATED FROM A040103 TO A05. 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 WHEN THE USER TRIED TO REMOVE IT FROM THE INSTRUMENT, THE SCREW PORTION BROKE AND WAS DIFFICULT TO REMOVE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION CLARIFIED THE INITIAL ALLEGATION. IT WAS REPORTED THAT THE TIP OF THE TAP WAS "LACKED" AND THERE WAS RECOGNITION FAILURE WITH THE TRACKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559301 SURETRAK¿ II UNIVERSAL TRACKER, LARGE PASSIVE FIGHTER ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 961-581 150728 00721902467684

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown