BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMESH X-DRIVE SELF TAPPING 1.5 MM SCREW

    MDR report key: 3863950 · Received June 10, 2014

    Report

    Report Number
    2021898-2014-00193
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JEY
    PMA / PMN Number
    K973145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    PROTEINACEOUS DEBRIS WAS OBSERVED ON THE EXTERIOR OF THE SCREW. THE RETURNED SCREW WAS BROKEN AT THE FIRST THREAD AWAY FROM THE SCREW HEAD. THE REST OF THE SCREW TAIL WAS NOT RETURNED. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. (B)(4).

    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 TIMESH SCREW BROKE DURING SURGERY. IT WAS ALSO REPORTED THAT THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340905 TIMESH X-DRIVE SELF TAPPING 1.5 MM SCREW PLATE, BONE JEY MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1