BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMESH STRAIGHT PLATE 1H X 1H 12MM

    MDR report key: 6112903 · Received November 18, 2016

    Report

    Report Number
    2021898-2016-00421
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JEY
    UDI-DI
    00673978002682
    PMA / PMN Number
    K973145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE STRAIGHT PLATE SHAFT WAS RETURNED. ONE OF THE EYELETS OF THE STRAIGHT PLATE SHAFT WAS OBSERVED TO BE FRACTURED OPEN AND DISTORTED. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE STATE THAT DISASSEMBLY, BENDING, OR BREAKAGE OF ANY OR ALL TIMESH COMPONENTS CAN OCCUR. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PLATE BROKE DURING SURGERY. ACCORDING TO THE REPORT, THE PHYSICIAN REPLACED THE PLATE TO COMPLETE THE SURGERY. REPORTEDLY, THE PATIENT WAS WELL AND NO FRAGMENT REMAINED IN THEIR BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765526 TIMESH STRAIGHT PLATE 1H X 1H 12MM PLATE, BONE JEY MEDTRONIC NEUROSURGERY TV52045 00673978002682

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR