BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 4041117 · Received August 27, 2014

    Report

    Report Number
    1723170-2014-00900
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 27, 2014
    Report Date
    November 9, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K990214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    RMA ISSUED. REPLACEMENT OPEN SPINE CLAMP SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT OPEN SPINE CLAMP FINDS THAT, AS REPORTED, THE RETAINER RING ON THE TIP OF THE ADJUSTMENT SCREW HAS BEEN PULLED OFF BY OVER-TURNING THE SCREW TO OPEN THE CLAMP. OTHERWISE, THE CLAMP IS IN GOOD CONDITION. CLAMP IS TWO YEARS OLD. PHYSICAL DAMAGE - PIECES MISSING - DIRECTLY CAUSED EVENT.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, OR MATERIALS COORDINATOR, REPORTED THAT, WHILE IN A SPINAL FUSION PROCEDURE, THE WASHER ON THEIR OPEN SPINE CLAMP BROKE. PER THE SURGEON, ALL PIECES WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE SPINE CLAMP BROKE AFTER THE SURGERY WAS COMPLETED, WHEN THE SURGEON WAS REMOVING THE SPINE CLAMP FROM THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521570 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120402

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR