BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 14755255 · Received June 21, 2022

    Report

    Report Number
    1723170-2022-00942
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    May 14, 2014
    Report Date
    June 21, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CHENG, E.Y, NARANJE, S.M., RITENOUR, E.R. RADIATION DOSIMETRY OF INTRAOPERATIVE CONE-BEAM COMPARED WITH CONVENTIONAL CT FOR RADIOFRE QUENCY ABLATION OF OSTEOID OSTEOMA. THE JOURNAL OF BONE <(>&<)> JOINT SURGERY. 2014. 96:735-42 HTTP://DX.DOI.ORG/10.2106/JBJS.M.00874 BACKGROUND: RADIOFREQUENCY (RF) ABLATION IS THE STANDARD OF CARE FOR THE SURGICAL TREATMENT OF NON-SPINAL OSTEOID OSTEOMA AND HAS GREATLY REDUCED MORBIDITY ASSOCIATED WITH SURGICAL EXCISION. PRECISE PLACEMENT OF THE RF ABLATION PROBE IS NECESSARY TO AVOID INCOMPLETE ABLATION. LIMITING RADIATION EXPOSURE IS ESPECIALLY ADVANTAGEOUS IN THE PEDIATRIC POPULATION IN WHOM OSTEOID OSTEOMA FREQUENTLY OCCURS. THE AIM OF THIS STUDY WAS TO COMPARE THE RADIATION DOSIMETRY AND CLINICAL OUTCOMES AMONG PATIENTS TREATED WITH RF ABLATION USING THREE DIFFERENT LOCALIZATION TECHNIQUES. METHODS: CASE-CONTROL METHODS WERE USED TO ANALYZE SIXTY-SIX CASES. PATIENTS WERE CATEGORIZED INTO THREE TREATMENT GROUPS: (1) INTRA OPERATIVE THREE-DIMENSIONAL CONE-BEAM CT (COMPUTED TOMOGRAPHY) IMAGING (O-ARM) WITH SURGICAL NAVIGATION (STEALTHSTATION S7), (2) INTRAOPERATIVE THREE-DIMENSIONAL IMAGING (O-ARM) ONLY, AND (3) RADIOLOGY SUITE-BASED DIAGNOSTIC CT IMAGING. RADIATION DOSIMETRY AND CLINICAL OUTCOME WERE ANALYZED WITH USE OF THE DOSE-LENGTH PRODUCT AND LOCAL-RELAPSE-FREE SURVIVAL, RESPECTIVELY. RESULTS: MEAN AGE WAS NINETEEN YEARS FOR THE TWENTY-THREE PATIENTS IN GROUP 1, TWENTY YEARS FOR THE SEVEN PATIENTS IN GROUP 2, AND NINETEEN YEARS FOR THE THIRTY-SIX PATIENTS IN GROUP 3. MEAN FOLLOW-UP WAS FIFTY-THREE MONTHS. THE MEAN RADIATION DOSE FOR GROUPS 1, 2, AND 3 WAS 446.62, 379.78, AND 1058.83 MGY-CM, RESPECTIVELY. SIGNIFICANT (P <(><<)> 0.05) DIFFERENCES IN THE RADIATION DOSE EXISTED BETWEEN GROUPS 1 AND 3 AND BETWEEN GROUPS 2 AND 3, WHEREAS NO DIFFERENCE WAS FOUND BETWEEN GROUPS 1 AND 2. LOCAL-REMISSION-FREE SURVIVAL AT THREE YEARS FOR GROUPS 1, 2, AND 3 WAS 84.7% (95% CONFIDENCE INTERVAL [CI], 64.5% TO 100%), 100% (95% CI, 100% TO 100%), AND 90.7% (95% CI, 80.7% TO 100%), RESPECTIVELY. FIFTY-EIGHT (92%) OF THE SIXTY-THREE FOLLOWED PATIENTS WERE ASYMPTOMATIC AT THE LATEST FOLLOW-UP VISIT. CONCLUSIONS: RF ABLATION USING INTRAOPERATIVE CONE-BEAM CT IMAGING, WITH OR WITHOUT SURGICAL NAVIGATION, WAS ASSOCIATED WITH A SIGNIFICANTLY LOWER RADIATION DOSE COMPARED WITH ABLATION USING A RADIOLOGY SUITE-BASED CT TECHNIQUE. ABLATION USING EACH OF THE THREE IMAGING TECHNIQUES WAS EQUALLY EFFECTIVE IN TREATING OSTEOID OSTEOMAS WITH A SIMILAR RISK OF RELAPSE. REPORTABLE EVENTS: ONE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION THAT REQUIRED IRRIGATION AND DEBRIDEMENT AND SKIN GRAFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546694 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Required Intervention