BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEDGE PEDICLE SCREW FIXATION SYSTEM

    MDR report key: 10086623 · Received May 26, 2020

    Report

    Report Number
    10086623
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    May 11, 2020
    Report Date
    May 21, 2020
    Manufacturer
    SPINAL RESOURCES, INC.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF PREVIOUS IMPLANT HARDWARE FROM PREVIOUS SURGERY. LOCKING CAPS INTENDED TO BE REMOVABLE BUT WERE UNABLE TO BE REMOVED LED TO ADDITIONAL SURGICAL MANEUVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551680 SWEDGE PEDICLE SCREW FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB SPINAL RESOURCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA