BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERWATCH

    MDR report key: 7612200 · Received June 18, 2018

    Report

    Report Number
    1067095-2018-00004
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Date of Event
    June 15, 2018
    Report Date
    June 15, 2018
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    NKB
    PMA / PMN Number
    K161842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO RADIOGRAPHS OR IMAGES WERE PROVIDED. NO PATIENT INJURY REPORTED WITH THIS EVENT. SURGERY WAS COMPLETED WITHOUT INCIDENT.

    Description of Event or Problem · 1

    NEAR THE END OF THE INITIAL SPINAL FUSION SURGERY, THE PEDICLE SCREWDRIVER TIP FRACTURED INTO THE SHAFT OF THE PEDICLE SCREW. THE SURGEON NOTED THE FRAGMENT AND ELECTED TO LEAVE IT. THE ROD WAS FIXATED TO THE BONE SCREW CAPTURING THE FRAGMENT SECURELY. THE SURGERY WAS COMPLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450971 OVERWATCH THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB SPINAL ELEMENTS 108-107-01-L 182-17402

    Patients

    Seq Age Sex Outcome Treatment
    1