BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE ANCHOR 020-1101 WITH ALIGNMENT ROD

    MDR report key: 5012292 · Received August 18, 2015

    Report

    Report Number
    1723170-2015-01005
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    July 28, 2015
    Report Date
    August 18, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL PATIENT IDENTIFIER WAS (B)(6) WHICH WOULD NOT FIT IN THE FIELD DUE TO CHARACTER LIMITATIONS. PATIENT WEIGHT WAS NOT PROVIDED. DEVICE MANUFACTURE DATE WAS UNAVAILABLE AS THE DEVICE WAS DISCARDED AND NO LOT NUMBER WAS PROVIDED. OPERATOR OF DEVICE IS A MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE, SPECIALLY TRAINED TO USE THE LASER INDUCED THERMAL THERAPY SYSTEM. PRODUCT IS CLASS I FOR US REGULATIONS AND DOES NOT REQUIRE A 510(K) DESIGNATION. THE ACCOUNT DISPOSED OF THE BONE ANCHOR AFTER THE CASE. NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SURGEON NOTED THAT THE PATIENT HAD A SOFT SKULL DUE TO HIS AGE WHICH LIKELY CONTRIBUTED TO THE ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A CRANIAL LASER INDUCED THERMAL THERAPY THE SURGEON NOTED THAT THE TITANIUM BONE ANCHOR HAD A TRAJECTORY THAT DID NOT ALIGN WITH HIS PLAN. THIS WAS NOTED DURING THE MRI PRESCAN PRIOR TO INTRODUCING LASER FIBERS INTO THE ANATOMY. AFTER NOTING THE INCORRECT INSTRUMENT PLACEMENT, THE SURGEON CONTINUED WITH THE SURGERY WITHOUT ISSUE. THEY DID NOT REMOVE OR ADJUST THE BONE ANCHOR DURING THE SURGERY. THERE WAS NO IMPACT TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545737 BONE ANCHOR 020-1101 WITH ALIGNMENT ROD INSTRUMENT, SURGICAL, NON-POWERED HAO MEDTRONIC NAVIGATION, INC. (LOUISVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR