BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION® S7¿

    MDR report key: 15779978 · Received November 11, 2022

    Report

    Report Number
    1723170-2022-01856
    Event Type
    Injury
    Date Received
    November 11, 2022
    Date of Event
    June 30, 2022
    Report Date
    November 11, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: UNK_NAV_COMP, 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, 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.

    Description of Event or Problem · 0

    ADAMSKI, S., WECLEWICZ, M.M., ROCLAWSKI, M., PANKOWSKI, R., KLOC, W. MINIMALLY INVASIVE LATERAL OCCIPITOCERVICAL FIXATION: CASE SERIES AND TECHNIQUE DESCRIPTION. EUROPEAN SPINE JOURNAL. 2022. 31 (2714¿2722) HTTPS://DOI.ORG/10.1007/S00586-022-07278-9. ABSTRACT PURPOSE: OCCIPITOCERVICAL JUNCTION (OCJ) INSTABILITY IS COMMONLY TREATED WITH FXATION VIA OPEN POSTERIOR APPROACH. THE USE OF INTRAOPERATIVE NAVIGATION ALLOWS US TO PERFORM OCCIPITOCERVICAL FIXATION VIA MINIMALLY INVASIVE APPROACH. WE REPORT A SERIES OF PATIENTS TREATED WITH PERCUTANEOUS OCCIPITOCERVICAL FIXATION, DESCRIBING THE SURGICAL PROCEDURE IN DETAIL AND DISCUSSING THE TECHNIQUE. METHODS: WE PROSPECTIVELY ENROLLED 8 PATIENTS AFECTED BY OCJ INSTABILITY SECONDARY TO TRAUMA AND RHEUMATOID ARTHRITIS. TRAUMATIC PATIENTS WERE PREOPERATIVELY EVALUATED WITH CT SCAN AND MRI SCAN IF NEEDED. RHEUMATOID ARTHRITIS GROUP WAS EVALUATED WITH BOTH CT AND MR. PATIENTS UNDERWENT PERCUTANEOUS OCCIPITOCERVICAL FIXATION WITH THE ASSIST OF INTRAOPERATIVE 3D IMAGING AND NAVIGATION. ALL PATIENTS WERE FUNCTIONALLY AND RADIOLOGICALLY EVALUATED PRE-, AT 6 WEEKS, AND AT 1 YEAR POSTOPERATIVELY. RESULTS: PERCUTANEOUS OCCIPITOCERVICAL FIXATION WAS SUCCESSFULLY PERFORMED IN ALL OF THE PATIENTS. 33 SCREWS WERE PLACED. 29 (87.88%) WERE PLACED WITHOUT ANY PEDICLE BREACH. IN 3 (9.09%) SCREWS WE OBSERVED A MINOR; AND IN 1 (3.03%) SCREW WE OBSERVED A MAJOR PEDICLE BREACH. WE DID NOT HAVE ANY POSTOPERATIVE COMPLICATIONS. CONCLUSIONS: DESCRIBED METHOD OF OCCIPITOCERVICAL FIXATION IS A MINIMALLY INVASIVE METHOD THAT HAS A SIMILAR OUTCOME TO THE OPEN TEC HNIQUE. IT REQUIRES THE EXPERIENCE IN OPEN TECHNIQUES AND THE ASSIST OF INTRAOPERATIVE 3D IMAGING AND NAVIGATION TO BE PERFORMED EFFICIENTLY. REPORTABLE EVENTS: ONE PATIENT (12.5%) WAS OPERATED BEFORE ONE YEAR PERIOD 3 (9.09%) SCREWS WE OBSERVED A MINOR PEDICLE BREACH. 1 (3.03%) SCREW WE OBSERVED A MAJOR PEDICLE BREACH. 2 PATIENTS (25%) C3 AND C4 PEDICLES WERE INSTRUMENTED BECAUSE OF FRACTURED C2 PEDICLES ONE PATIENT (12.5%) WE INSTRUMENTED UNILATERALLY C2 (KIRCHNER WIRE WAS ACCIDENTALLY REMOVED WHILE TAPPING THE PEDICLE AND WE WERE UNABLE TO REINSERT IT DUE TO INSTABILITY OF THE CVJ), AND ON BOTH SIDES C3 AND C4 PEDICLES. ONE PATIENT HAD ONLY A PARTIAL INTRAARTICULAR FUSION AT C2/C3 AND C3/C4 LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2879064 STEALTHSTATION® S7¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733858

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention