BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMESH OPTIMIZED SELF DRILLING SCREWS, 4.0 MM

    MDR report key: 2153111 · Received June 17, 2011

    Report

    Report Number
    2021898-2011-00134
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    HRS
    PMA / PMN Number
    K974017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEAD OF THE SCREW HAD EXTENSIVE DAMAGE AND THE MATERIAL DISPLACEMENT WAS NOT DIRECTIONAL. IT IS UNK HOW THIS DAMAGE OCCURRED. PER THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE, BREAKAGE OF TIMESH COMPONENTS IS A KNOWN COMPLICATION. DAMAGE TO THE HEAD MAY OCCUR WHEN THE SCREW IS IMPROPERLY ENGAGED WITH THE DRIVER BLADE, PARTICULARLY IF THE DRIVER BLADE IS DULL. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. NO IMPACT TO PT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DOCTOR FOUND THE TAIL OF THE SCREW DAMAGED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMESH OPTIMIZED SELF DRILLING SCREWS, 4.0 MM HRS - PLATE, FIXATION, BONE HRS MEDTRONIC NEUROSURGERY TV01028

    Patients

    Seq Age Sex Outcome Treatment
    1