BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7

    MDR report key: 12481793 · Received September 16, 2021

    Report

    Report Number
    1723170-2021-02294
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 12, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D10: THE LOT NUMBER OF THE SHORT CLAMP WAS 170207. THE LOT NUMBER OF THE LONG CLAMP WAS 170425. H3, H6: THE SHORT CLAMP WAS RETURNED FOR PRODUCT ANALYSIS. THE RETURNED CLAMP HAS NO APPARENT PHYSICAL DAMAGE AND WAS FOUND TO BE FULLY FUNCTIONAL PER DESIGN. NO PROBLEM FOUND. THE LONG CLAMP WAS RETURNED FOR PRODUCT ANALYSIS. THE RETURNED CLAMP HAS NO APPARENT PHYSICAL DAMAGE AND WAS FOUND TO BE FULLY FUNCTIONAL PER DESIGN. NO PROBLEM FOUND. B01, C19, AND D14 ARE APPLICABLE TO BOTH PRODUCT ANALYSES. 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 734715, ( CLAMP SPINOUS PROCESS TALL) SERIAL/LOT #:UNKNOWN, UDI#: UNKNOWN AND PRODUCT ID: 9734716 (CLAMP SPINOUS PROCESS SHORT) SERIAL/LOT #: UNKNOWN , UDI#: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SPINE CLAMPS WERE HAVING ISSUES TIGHTENING DURING A CASE. THE REPRESENTATIVE REPORTED THAT THE CLAMP DID NOT HAVE IT'S FULL RANGE OF MOTION AND THE THREADS WERE NOT CATCHING TILL THE CLAMP WAS CLOSED FURTHER THAN NORMAL. DID NOT NOTICE ANY PHYSICAL DAMAGE ON THE CLAMPS. IMPACT TO THE PATIENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378681 STEALTHSTATION S7 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 "SEE H10..."| "SEE H10...."