BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 15976985 · Received December 14, 2022

    Report

    Report Number
    1723170-2022-02057
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    June 29, 2022
    Report Date
    January 27, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY. THIS VALUE REFLECTS THE MEAN AGE OF THE PATIENTS WHO UNDERWENT CORRECTIVE POSTERIOR FIXATION FOR CERVICAL SPINE INJURY AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE ARTICLE ACCEPTED DATE. THE ARTICLE CITATION IS INCLUDED. THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. 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 · 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

    TAKAMATSU, NOBUTOSHI, ET AL. ¿COMPARISON BETWEEN O-ARM NAVIGATION AND CONVENTIONAL FLUOROSCOPIC GUIDANCE IN CORRECTIVE POSTERIOR FIXATION FOR CERVICAL SPINAL INJURY.¿ THE JOURNAL OF MEDICAL INVESTIGATION, VOL. 69, NO. 3.4, 2022, PP. 273¿277., HTTPS://DOI.ORG/10.2152/JMI.69.273. SUMMARY: ABSTRACT : PURPOSE : TO COMPARE THE EFFECTIVENESS OF O-ARM NAVIGATION WITH THAT OF CONVENTIONAL FLUOROSCOPIC GUIDANCE IN CORRECTIVE POSTERIOR FIXATION FOR CERVICAL SPINAL INJURY. METHODS : THIS RETROSPECTIVE COMPARATIVE STUDY INVOLVED 11 CONSECUTIVE PATIENTS WHO UNDERWENT CORRECTIVE POSTERIOR FIXATION USING O-ARM NAVIGATION OR CONVENTIONAL FLUOROSCOPY FOR CERVICAL SPINAL INJURY BETWEEN FEBRUARY 2016 AND MAY 2021. PATIENT-SPECIFIC CHARACTERISTICS (AGE AND SEX), NUMBER OF SCREWS, NUMBER OF PEDICLE SCREWS, ACCURACY OF PEDICLE SCREW INSERTION, NUMBER OF VERTEBRAL BODIES FIXED, OPERATING TIME, AND LENGTH OF HOSPITAL STAY WERE ANALYZED USING THE T-TEST. A P-VALUE 0.05). CONCLUSION : O-ARM NAVIGATION CAN IMPROVE THE ACCURACY OF CERVICAL PEDICLE SCREW INSERTION. ITS INTRODUCTION COULD EXPAND THE INDICATIONS FOR USE OF PEDICLE SCREWS IN POSTERIOR FIXATION OF CERVICAL SPINAL INJURY BEYOND THOSE THAT ARE POSSIBLE USING CONVENTIONAL FLUOROSCOPY. REPORTABLE EVENTS: 1. THERE WERE 2 SCREWS THAT WERE REVISED INTRAOPERATIVELY IN THE O-ARM GROUP. 2. ACCORDING TO THE NEO CLASSIFICATION, THERE WAS ONE MINOR GRADE 1 (2MM) LATERAL SCREW BREACHES. SEE ATTACHED LITERATURE ARTICLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE REPORTED ADVERSE EVENTS WERE NOT RELATED TO ANY MEDTRONIC SYSTEMS OR PRODUCTS. IT WAS ALSO REPORTED THAT THE CAUSE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142715 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other