BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINOUS PROCESS TALL

    MDR report key: 8605308 · Received May 13, 2019

    Report

    Report Number
    1723170-2019-02321
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    May 8, 2019
    Report Date
    November 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE CLAMP 9734715 SPINOUS PROCESS TALL (160707) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND THAT THE RETAINER RING HAD BEEN PULLED FROM THE ADJUSTMENT SCREW AND WAS MISSING. AS IS, THE SCREW WOULD BE ABLE TO CLOSE THE CLAMP BUT NOT OPEN IT. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. 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 FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A NAVIGATION INSTRUMENT. THE CALLER INDICATED THAT THE LARGE SPINE CLAMP WAS BROKEN AND THE REPORTED PROBABLE CAUSE WAS THAT THE SURGEON OPENED THE CLAMP TOO MUCH CAUSING THE 2 WASHERS WHICH FIX THE SCREW TO GO AWAY. THE ISSUE OCCURRED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. THERE WAS NO DELAY IN PROCEDURE OR CHANGE IN PATIENT OUTCOME AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397748 SPINOUS PROCESS TALL ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9734715

    Patients

    Seq Age Sex Outcome Treatment
    1