BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 24151605 · Received January 22, 2026

    Report

    Report Number
    1723170-2026-00132
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    January 1, 2016
    Report Date
    March 9, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENTS IN THE STUDY. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND IS THEREFORE, UNAVAILABLE. H3) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    A MEDICAL ASSESSMENT WAS PERFORMED AND THE SOURCE OF THIS COMPLAINT IS A PUBLICATION BY SCHAEFER ET AL., 2025, DESCRIBING A RETROSPECTIVE STUDY OF 16 PATIENTS COMPARING THREE-DIMENSIONAL (3D) NAVIGATION USING THE MEDTRONIC STEALTHSTATION NAVIGATION SYSTEM VERSUS TRADITIONAL OPEN TECHNIQUES IN THE RESECTION OF TALOCALCANEAL (TC) COALITIONS. THE STUDY DESCRIBES 1. ONE OBESE PATIENT HAD DELAYED WOUND HEALING (MINOR) 2. ONE PATIENT HAD A SUPERFICIAL SKIN INFECTION 7 WEEKS AFTER SURGERY THAT WAS TREATED SUCCESSFULLY WITH ORAL ANTIBIOTICS (MINOR). 3. THREE PATIENTS UNDERWENT MORE THAN ONE O-ARM SPIN WITH A SINGLE PATIENT REQUIRING ADDITIONAL O-ARM SPINS DUE TO REPORTED TECHNICAL ISSUES BETWEEN THE O-ARM AND THE NAVIGATION SYSTEM (NEGLIGIBLE). OBESITY AND POOR WOUND HEALING, AND INHERENT MEDICAL OR SURGICAL RISKS ASSOCIATED WITH THE TC RESECTION PROCEDURE. BASED ON THE EVENT DESCRIPTION AND MEDICAL EXPERTISE, THE ADDITIONAL RADIATION EXPOSURE (NEGLIGIBLE) FROM REPEAT O-ARM SPINS WAS DETERMINED TO BE POSSIBLY RELATED TO THE DEVICE DUE TO TECHNICAL ISSUES BETWEEN THE O-ARM AND THE MEDTRONIC STEALTHSTATION NAVIGATION SYSTEM. THE REPEAT SPIN IN ONE PATIENT WAS REPORTEDLY RELATED TO REGISTRATION ISSUES. OTHER REPEAT SPINS WERE RELATED TO SURGICAL DECISION-MAKING, NOT THE DEVICE. ADDITIONAL HARMS OF DELAYED WOUND HEALING IN AN OBESE PATIENT (MINOR) AND A SUPERFICIAL SKIN INFECTION TREATED WITH ANTIBIOTICS (MINOR), WERE DEEMED NOT RELATED TO THE DEVICE AND MORE LIKELY RELATED TO PATIENT-SPECIFIC FACTORS SUCH AS OBESITY AND POSTOPERATIVE WOUND CARE. BASED ON THE MEDICAL SAFETY ASSESSMENT OF THIS EVENT, NO FURTHER ACTION IS RECOMMENDED. IF ADDITIONAL INFORMATION IS RECEIVED, PLEASE NOTIFY MEDICAL SAFETY FOR REASSESSMENT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    JACOB SCHAEFER MD , EMIL VARAS-RODRIGUEZ MPH , QUINN JOHNSON MD , ANTHONY STANS MD , A. NOELLE LARSON MD , TODD A. MILBRANDT MD, MS , EMMANOUIL GRIGORIOU MD , THREE-DIMENSIONAL NAVIGATION FOR TALOCALCANEAL COALITION RESECTION: A COMPARATIVE ANALYSIS, THE JOURNAL OF FOOT AND ANKLE SURGERY (2025), DOI: HTTPS://DOI.ORG/10.1053/J.JFAS.2025.11.015 ABSTRACT OBJECTIVE: TALOCALCANEAL (TC) COALITION IS AN ABNORMAL CONNECTION BETWEEN THE TALUS AND CALCANEUS, CAUSING PAINFUL, RESTRICTED SUBTALAR MOTION, RECURRENT ANKLE SPRAINS, AND RIGID FLATFOOT. THE PURPOSE OF THIS STUDY WAS TO COMPARE 3D-NAVIGATION TO TRADITIONAL OPEN TECHNIQUES IN RESECTION OF TC COALITIONS. PATIENT AND METHODS: PATIENTS WHO UNDERWENT TC COALITION RESECTION WITH THE ASSISTANCE OF INTRA OPERATIVE 3-D NAVIGATION (STUDY COHORT = 12 PATIENTS, 14 FEET) OR THE TRADITIONAL NON-NAVIGATED APPROACH (CONTROL GROUP = 4 PATIENTS, 5 FEET) AT A SINGLE TERTIARY REFERRAL CENTER WERE REVIEWED. OPERATIVE TIME (OT), ANESTHESIA TIME (AT), TOURNIQUET TIME (TT), BLOOD LOSS (EBL), LENGTH OF HOSPITAL STAY (LOS), COMPLICATIONS, DURATION OF IMMOBILIZATION POSTOPERATIVELY, AND AVERAGE EFFECTIVE DOSE OF RADIATION IN MILLISIEVERTS (MSV) WERE REVIEWED. RESULTS: OT (P=0.97), EBL (P=0.75), LOS (P=0.58), AT (P=0.46), AND TT (P=0.76) DID NOT DIFFER BETWEEN GROUPS. MEAN DURATION OF POSTOPERATIVE IMMOBILIZATION WAS 2 WEEKS SHORTER FOR THE NAVIGATED GROUP BUT NOT STATISTICALLY SIGNIFICANT (P=0.11). TWO COMPLICATIONS OCCURRED IN THE NAVIGATED GROUP; ONE OBESE PATIENT (BMI=34 KG/M2) HAD DELAYED WOUND HEALING, AND ANOTHER A SUPERFICIAL SKIN INFECTION. THE AVERAGE EFFECTIVE DOSE OF RADIATION FOR ALL PATIENTS (N=12) IN THE NAVIGATED GROUP WAS 0.0081 MSV. THE AVERAGE DOSE FOR PATIENTS UNDERGOING ONLY ONE INTRAOPERATIVE CT SPIN (N=9) WAS 0.0052 MSV. CONCLUSIONS: NAVIGATED TC COALITION EXCISION HAD COMPARABLE OT, EBL, LOS, AT, AND TT TO TRADITIONAL NON-NAVIGATED APPROACH PATIENTS. THE ADDITION OF INTRAOPERATIVE 3D NAVIGATION PROVIDES PRECISE RESECTION GUIDANCE WITHOUT SIGNIFICANTLY INCREASED SURGICAL TIME WITH COMPARABLE TOTAL EFFECTIVE RADIATION DOSE TO THE TRADITIONAL USE OF INTRA-OPERATIVE FLUOROSCOPY. 1. ONE OBESE PATIENT HAD DELAYED WOUND HEALING. 2. ONE PATIENT HAD A SUPERFICIAL SKIN INFECTION 7 WEEKS AFTER SURGERY THAT WAS TREATED SUCCESSFULLY WITH ORAL ANTIBIOTICS. 3. A SINGLE PATIENT UNDERWENT THREE O-ARM SPINS IN A SINGLE SURGERY DUE TO REPORTED TECHNICAL ISSUES BETWEEN THE O-ARM AND THE NAVIGATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208685 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Other