BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOBAR SPINAL SYSTEM

    MDR report key: 866047 · Received June 15, 2007

    Report

    Report Number
    3003807094-2007-00002
    Event Type
    Injury
    Date Received
    June 15, 2007
    Date of Event
    March 13, 2007
    Report Date
    May 22, 2007
    Manufacturer
    SCIENT'X USA, INC.
    Product Code
    NQP
    PMA / PMN Number
    K013447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BLOCKER NUT CROSS-THREADED DURING INSTALLATION ON PEDICLE SCREW.

    Description of Event or Problem · 1

    IN 2007, PAT. TREATED SINGLE LEVEL FUSION. IN 2007, PAT. SYMPTOMATIC, REVISION SURGERY, THREE PEDICAL SCREWS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOBAR SPINAL SYSTEM PEDICLE SCREW NQP SCIENT'X USA, INC. A44L

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other