BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 8467961 · Received March 30, 2019

    Report

    Report Number
    1723170-2019-01450
    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
    PMA / PMN Number
    K990214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: UDI NUMBER UPDATED. THE INST 9731780 N/A OPEN SPINE CLAMP, RADIO (LOT# 150227) WAS RETURNED FOR ANALYSIS. THROUGH VISUAL/PHYSICAL EXAMINATION AND FUNCTIONAL TESTING ANALYSIS FOUND PHYSICAL DAMAGE. THE ADJUSTMENT SCREW OF THE RETURNED CLAMP WAS BENT CAUSING ISSUES CLOSING THE CLAMP. THE HEAD OF THE SCREW WAS ALSO DAMAGED WITH TOOL MARKS. 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 SCREW THREAD WAS DEFRAGMENTED ON THE OPEN SPINE CLAMP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260842 OPEN SPINE CLAMP, TITANIUM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9731780 150227

    Patients

    Seq Age Sex Outcome Treatment
    1