BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMESH STRAIGHT PLATE, 1 X 1, 12MM SHAFT

    MDR report key: 2254129 · Received August 18, 2011

    Report

    Report Number
    2021898-2011-00195
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JEY
    PMA / PMN Number
    K973145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EYELET OF THE PLATE WAS BROKEN AND BENT OPEN. THE TAB NORMALLY ATTACHED TO THE PLATE WAS NOT RETURNED. IT IS UNKNOWN WHEN OR HOW THIS DAMAGE OCCURRED. PER THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE, BREAKAGE OF TIMESH COMPONENTS IS A KNOWN COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. NO IMPACT TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DOCTOR FOUND FISSURES ON THE EDGE OF THE CONNECTOR DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMESH STRAIGHT PLATE, 1 X 1, 12MM SHAFT JEY - PLATE, BONE JEY MEDTRONIC NEUROSURGERY TV92961

    Patients

    Seq Age Sex Outcome Treatment
    1