BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP, THORACIC, RADIOLUCENT

    MDR report key: 5554873 · Received April 7, 2016

    Report

    Report Number
    1723170-2016-00509
    Event Type
    Malfunction
    Date Received
    April 7, 2016
    Date of Event
    March 11, 2016
    Report Date
    May 9, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K990214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE LOT NUMBERS NOT AVAILABLE. DEVICE MANUFACTURING DATES ARE DEPENDENT ON LOT NUMBERS, THEREFORE, UNAVAILABLE. RETURN REQUESTED FOR 2 THORACIC CLAMPS. NO PARTS WERE REPLACED. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. NO FURTHER ISSUES HAVE BEEN REPORTED. PARTS NOT RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBERS FOR BOTH THORACIC CLAMPS NOW PROVIDED: 140923 AND 100927. DEVICE MANUFACTURING DATE FOR BOTH THORACIC CLAMPS NOW PROVIDED: LOT #: 140923 = MANUFACTURING DATE: 09/23/2014 AND LOT #: 100927 = MANUFACTURING DATE: 09/27/2010.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM A SITE THAT THEIR 2 SPINOUS PROCESS CLAMPS HAD WORN SCREWS. REPLACEMENT DEVICES WERE REQUESTED. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209273 CLAMP, THORACIC, RADIOLUCENT NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 140923, 100927

    Patients

    Seq Age Sex Outcome Treatment
    1