BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP, THORACIC, RADIOLUCENT

    MDR report key: 8467958 · Received March 30, 2019

    Report

    Report Number
    1723170-2019-01448
    Event Type
    Malfunction
    Date Received
    March 30, 2019
    Date of Event
    March 1, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994201263
    PMA / PMN Number
    K990214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLAMP, 9733148, THORACIC, RADIOLUCENT (LOT# 150327) WAS RETURNED FOR ANALYSIS. THROUGH FUNCTIONAL TESTING AND VISUAL/PHYSICAL EXAMINATION ANALYSIS FOUND PHYSICAL DAMAGE. THE ADJUSTMENT SCREW OF THE RETURNED CLAMP HAD DEBRIS IN THE THREADS CAUSING DIFFICULTY IN THE TRAVEL OF THE SCREW. THE CLAMP WAS OTHERWISE FUNCTIONAL. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE HAD A BROKEN INSTRUMENT THAT NEEDED REPLACEMENT. THE THORACIC CLAMP'S SCREW THREAD WAS DEFRAGMENTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260800 CLAMP, THORACIC, RADIOLUCENT INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733148 150327 00613994201263

    Patients

    Seq Age Sex Outcome Treatment
    1