BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 20481017 · Received October 18, 2024

    Report

    Report Number
    1723170-2024-03195
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    February 1, 2024
    Report Date
    October 18, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5) PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY. B3) THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE ACCEPTED 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. G2) 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: FEIZI, A., BELL, C. E., ROYTMAN, G. R., PARK, N., WANG, A., TOMMASINI, S., <(>&<)> WIZNIA, D. (2024). USING COMPUTED TOMOGRAPHY-BASED THREE-DIMENSIONAL MODELING AND COMPUTER NAVIGATION FOR MINIMALLY INVASIVE CORE DECOMPRESSION AND ADJUVANT ORTHOBIOLOGIC THERAPY OF FEMORAL HEAD AVASCULAR NECROSIS. ARTHROPLASTY TODAY, 26, 101337. HTTPS://DOI.ORG/10.1016/J.ARTD.2024.101337. ABSTRACT: AVASCULAR NECROSIS OF THE FEMORAL HEAD IS A DEBILITATING CONDITION THAT CAN LEAD TO FEMORAL HEAD COLLAPSE. CORE DECOMPRESSION WITH ADJUVANT CELLULAR THERAPIES, SUCH AS BONE MARROW ASPIRATE CONCENTRATE, DELAYS DISEASE PROGRESSION AND IMPROVES OUTCOMES. HOWEVER, INCONSISTENT RESULTS IN THE LITERATURE MAY BE DUE TO LIMITATIONS IN SURGICAL TECHNIQUE AND DIFFICULTY IN TARGETING THE NECROTIC LESIONS. HERE, WE PRESENT A SURGICAL TECHNIQUE UTILIZING COMPUTED TOMOGRAPHY-BASED THREE-DIMENSIONAL MODELING AND INSTRUMENT TRACKING TO GUIDE THE THERAPY TO THE CENTER OF THE LESION. THIS METHOD MINIMIZES THE NUMBER OF ATTEMPTS TO REACH THE LESION AND CONFIRMS THE THREE-DIMENSIONAL POSITIONING OF THE INSTRUMENTATION WITHIN THE LESION. OUR TECHNIQUE MAY IMPROVE THE OUTCOMES OF CORE DECOMPRESSION AND ADJUVANT THERAPY AND PREVENT OR DELAY HIP COLLAPSE IN PATIENTS WITH FEMORAL HEAD AVASCULAR NECROSIS. REPORTED EVENT: THIRTY-ONE PATIENTS WERE TREATED FOR AVASCULAR NECROSIS (AVN) OF THE FEMUR BY USING MINIMALLY INVASIVE CORE DECOMPRESSION AND ADJUVANT ORTHOBIOLOGIC THERAPY. ONE PATIENT REQUIRED 2 NEEDLE ENTRY ATTEMPTS DUE TO A SLIGHT DEVIATION OF THE NEEDLE AT THE SOFT-TISSUE AND BONE BOUNDARY. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716119 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown