BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW DRIVER, MODULAR SCREW REFORM SYSTEM

    MDR report key: 7710267 · Received July 23, 2018

    Report

    Report Number
    3005739886-2018-00014
    Event Type
    Malfunction
    Date Received
    July 23, 2018
    Date of Event
    July 20, 2017
    Report Date
    July 20, 2017
    Manufacturer
    PRECISION SPINE, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CORRECTIVE ACTIONS ARE BEING RECOMMENDED AT THIS TIME SINCE A DESIGN CHANGE HAS BEEN IMPLEMENTED. (B)(4). THESE DESIGN CHANGES WERE IMPLEMENTED SUBSEQUENT TO THE MANUFACTURE OF THE COMPLAINT PRODUCT.

    Description of Event or Problem · 1

    UPON INSPECTION OF AN INSTRUMENT TRAY RETURNED TO PRECISION SPINE, INC. ON (B)(6) 2017, IT WAS IDENTIFIED THAT THE MODULAR REFORM SCREWDRIVER (39-MD-0700) HAD A BROKEN TIP. FOLLOW-UP ATTEMPTS FOR ADDITIONAL DETAILS OF HOW THE DRIVER BROKE WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551913 SCREW DRIVER, MODULAR SCREW REFORM SYSTEM SCREWDRIVER HXX PRECISION SPINE, INC 00009SM-R

    Patients

    Seq Age Sex Outcome Treatment
    1