BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7¿

    MDR report key: 16323261 · Received February 8, 2023

    Report

    Report Number
    1723170-2023-00180
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    October 13, 2021
    Report Date
    May 3, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE OR DATE OF BIRTH: PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. SEX: PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. WEIGHT: PLEASE NOTE THAT THIS WEIGHT IS THE AVERAGE WEIGHT OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL WEIGHT OF PATIENTS INVOLVED WAS NOT PROVIDED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    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

    PAUL KENDLBACHER, DIMITRI TKATSCHENKO, MARCUS CZABANKA, SIMON BAYERL, GEORG BOHNER, JOHANNES WOITZIK, PETER VAJKOCZY, AND NILS HECHT. WORKFLOW AND PERFORMANCE OF INTRAOPERATIVE CT, CONE-BEAM CT, AND ROBOTIC CONE-BEAM CT FOR SPINAL NAVIGATION IN 503 CONSECUTIVE PATIENTS. NEUROSURGICAL FOCUS 1 (2022). DOI: 10.3171/2021.10.FOCUS21467 OBJECTIVE A DIRECT COMPARISON OF INTRAOPERATIVE CT (ICT), CONE-BEAM CT (CBCT), AND ROBOTIC CONE-BEAM CT (RCBCT) HAS BEEN NECESSARY TO IDENTIFY THE IDEAL IMAGING SOLUTION FOR EACH INDIVIDUAL USER¿S NEED. HEREIN, THE AUTHORS SOUGHT TO ANALYZE WORKFLOW, HANDLING, AND PERFORMANCE OF ICT, CBCT, AND RCBCT IMAGING FOR NAVIGATED PEDICLE SCREW INSTRUMENTATION ACROSS THE ENTIRE SPINE PERFORMED WITHIN THE SAME SURGICAL ENVIRONMENT BY THE SAME GROUP OF SURGEONS. METHODS BETWEEN 2014 AND 2018, 503 CONSECUTIVE PATIENTS RECEIVED 2673 NAVIGATED PEDICLE SCREWS USING ICT (N = 1219), CBCT (N = 646), OR RCBCT (N = 808) IMAGING DURING THE FIRST 24 MONTHS AFTER THE ACQUISITION OF EACH MODALITY. CLINICAL AND DEMOGRAPHIC DATA, WORKFLOW, HANDLING, AND SCREW ASSESSMENT AND ACCURACY WERE ANALYZED. RESULTS INTRAOPERATIVE CT SHOWED IMAGE QUALITY AND WORKFLOW ADVANTAGES FOR CERVICOTHORACIC CASES, OBESE PATIENTS, AND LONG-SEGMENT INSTRUMENTATION, WHEREAS CBCT AND RCBCT OFFERED INDEPENDENT HANDLING, AROUND-THE-CLOCK AVAILABILITY, AND THE OPTION OF PERFORMING 2D FLUOROSCOPY. ALL MODALITIES PERMITTED RELIABLE INTRAOPERATIVE SCREW ASSESSMENT. NAVIGATED SCREW REVISION WAS POSSIBLE WITH EACH MODALITY AND YIELDED FINAL ACCURACY RATES 92% IN ALL GROUPS (ICT 96.2% VS CBCT 92.3%, P 0.001) WITHOUT A DIFFERENCE IN THE ACCURACY OF CERVICAL PEDICLE SCREW PLACEMENT OR THE RATE OF SECONDARY SCREW REVISION SURGERIES. CONCLUSIONS CONTINUOUS TRAINING AND AN INDIVIDUAL SETUP OF ICT, CBCT, AND RCBCT HAS BEEN SHOWN TO PERMIT SAFE AND PRECISE NAVIGATED POSTERIOR INSTRUMENTATION ACROSS THE ENTIRE SPINE WITH RELIABLE SCREW ASSESSMENT AND THE OPTION OF IMMEDIATE REVISION. THE PERCEIVED HIGHER IMAGE QUALITY AND LARGER SCAN AREA OF ICT SHOULD BE WEIGHED AGAINST THE AROUND-THE-CLOCK AVAILABILITY OF CBCT AND RCBCT TECHNOLOGY WITH THE OPTION OF SINGLE-HANDED ROBOTIC IMAGE ACQUISITION. REPORTED EVENTS: - TOTAL NUMBER OF NAVIGATED SCREWS WERE 646 WHERE INITIALLY MISPLACED SCREWS GREATER THAN OR EQUAL TO 2MM OCCURRED WITH 86 SCREWS (13.3%), AND IMMEDIATE INTRAOPERATIVE REPOSITIONING/REVISED SCREWS OCCURRED WITH 36 SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2315740 STEALTHSTATION® S7¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733858

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female