BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVLOCK

    MDR report key: 18092953 · Received November 8, 2023

    Report

    Report Number
    1723170-2023-02188
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 17, 2023
    Report Date
    November 8, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3) NO PARTS HAVE BEEN RETURNED FOR ANALYSIS. CONTINUATION OF D10: PRODUCT ID 9735665 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 9735024 (220622); PRODUCT TYPE: 2543-MNAV - SYSTEM; IMPLANT DATE N/A; EXPLANT DATE N/A MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHILE A 8.5 MM DIAMETER SCREW WAS BEING IMPLANTED IT CONTACTED HARD BONE. WHILE ADVANCING IT INTO THE PEDICLE THE TIP OF THE SCREWDRIVER BROKE OFF INTO THE SCREW HEAD. THE TIP THAT BROKE FREE FROM THE DRIVER WAS SUCCESSFULLY RETRIEVED FROM THE SADDLE OF THE SCREW USING THE SHARP AWL WHICH WAS DAMAGED IN THE PROCESS. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND NO REPORTED DELAY TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582527 NAVLOCK ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9734678 210919

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male SEE H10...