BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMESH STRAIGHT PLATE, 1 X 1, 12MM SHAFT

    MDR report key: 2063119 · Received March 22, 2011

    Report

    Report Number
    2021898-2011-00069
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 23, 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

    (B)(4). THE EYELET OF THE PLATE WAS BROKEN AND BENT OPEN. THE TAB NORMALLY ATTACHED TO THE PLATE WAS MISSING. 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 PATIENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE SURGERY, THE DOCTOR FOUND THE PLATE BROKEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK