BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP DRIVER

    MDR report key: 8467960 · Received March 30, 2019

    Report

    Report Number
    1723170-2019-01449
    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

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE LOT NUMBER UPDATED. THE INST (B)(4) DRIVER OPEN SPINE CLAMP (LOT# 160126) WAS RETURNED FOR ANALYSIS. THROUGH VISUAL/PHYSICAL EXAMINATION ANALYSIS FOUND PHYSICAL DAMAGE. THE RETURNED DRIVER HAD A VERY WORN HANDLE WITH A ROUGH SURFACE. THE PRINTED ARTWORK WAS NEARLY UNREADABLE. THE TIP OF THE DRIVER WAS SLIGHTLY ROUNDED OUT BUT STILL USABLE. 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.

    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 THREAD OF THE OPEN SPINE CLAMP DRIVER WAS DEFRAGMENTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260841 OPEN SPINE CLAMP DRIVER INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9730027 160126

    Patients

    Seq Age Sex Outcome Treatment
    1