BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 23522534 · Received November 11, 2025

    Report

    Report Number
    1723170-2025-03698
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 11, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5) PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY A2) THIS VALUE REFLECTS THE MEAN AGE OF THE PATIENTS WHO UNDERWENT THE SPINAL SURGERY AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A3) THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT THE SPINAL SURGERY AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B3) THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE PUBLISHED DATE. B5) THE ARTICLE CITATION IS INCLUDED. D4) THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. G3) NO 510K PROVIDED AS SYSTEM IS UNKNOWN. H3) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) DEVICE MANUFACTURING DATE IS UNAVAILABLE. 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

    CITATION: TIMMER, R. A., VAN DER ZWAAL, P., <(>&<)> MEYLAERTS, S. A. G. (2025A). ACCURACY OF 3D-NAVIGATED SCREW FIXATION IN PELVIC RING FRACTURES: A SINGLE-CENTRE CONSECUTIVE OBSERVATIONAL CASE SERIES. EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY <(>&<)>AMP; TRAUMATOLOGY, 35(1). HTTPS://DOI.ORG/10.1007/S00590-025-04541-9 ABSTRACT: PURPOSE: CONVENTIONAL 2D FLUOROSCOPY-BASED SCREW FIXATION OF PELVIC RING FRACTURES HAS HIGH SCREW MISPLACEMENT RATES AND CAN BE TECHNICALLY CHALLENGING. IMPLEMENTATION OF 3D IMAGE GUIDANCE IS PRESUMED TO SIMPLIFY SCREW PLACEMENT AND IMPROVE PROCEDURAL SAFETY. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE ACCURACY OF 3D NAVIGATION IN PERCUTANEOUS SCREW FIXATION OF PELVIC RING FRACTURES. METHODS: A CONSECUTIVE CASE SERIES INCLUDING ALL PATIENTS UNDERGOING 3D-GUIDED SCREW FIXATION OF PELVIC RING FRACTURES BETWEEN 2019 AND 2022 WAS CONDUCTED. PRIMARY STUDY ENDPOINTS WERE SCREW MISPLACEMENT, NEUROLOGICAL COMPLICATIONS, AND SURGICAL SITE INFECTIONS. DATA WERE ANALYSED USING DESCRIPTIVE STATISTICS. RESULTS: A TOTAL OF 90 CONSECUTIVE PATIENTS (180 SCREWS) WERE INCLUDED, WITH 120 TRANSSACRAL-TRANSILIAC SCREWS (TSTI) AND 60 SACRAL-ILIAC (SI) SCREWS USED FOR POSTERIOR FIXATION, 5 RETROGRADE TRANSPUBIC SCREWS PLACED FOR ANTERIOR FIXATION, AND 23 ANTEGRADE SCREWS PLACED INTO THE SUPERIOR RAMI. FOR TWO PATIENTS (2.7%), SCREW MISPLACEMENTS WERE OBSERVED. NO NEUROLOGICAL COMPLICATIONS OCCURRED DUE TO SCREW MISPLACEMENT. CONCLUSIONS: THE RESULT OF THE CURRENT STUDY SHOWS THAT 3D NAVIGATION PROVIDES EXCELLENT SCREW PLACEMENT ACCURACY, WITH MINIMAL SCREW MISPLACEMENTS AND NO NEUROLOGICAL COMPLICATIONS DUE TO SCREW MISPLACEMENT. REPORTED EVENT: 1. SCREW MISPLACEMENT OCCURRED IN 2 OF 90 PATIENTS. 2. THREE PATIENTS WERE DIAGNOSED WITH SURGICAL SITE INFECTION. 3. MATERIAL-RELATED COMPLICATIONS REQUIRED SCREW REMOVAL IN 14 PATIENTS (16.7%). THE MAJORITY WERE DUE TO PAIN, FOLLOWED BY SCREW LOOSENING OF THE SACRAL-ILIAC (SI) SCREWS IN SIX PATIENTS AND BACKING OUT OF PUBIC RAMUS SCREW IN TWO PATIENTS. IN ADDITION, ONE PATIENT REQUIRED REMOVAL OF A PUBIC RAMUS SCREW DUE TO BREAKAGE. PLEASE SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2542114 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female