BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1792185 · Received August 10, 2010

    Report

    Report Number
    2242816-2010-00113
    Event Type
    Injury
    Date Received
    August 10, 2010
    Report Date
    July 14, 2010
    Manufacturer
    EBI, LLC
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, "POSSIBLE ADVERSE EFFECTS INCLUDE, BUT ARE NOT LIMITED TO:""1. BENDING, LOOSENING OR FRACTURE OF THE IMPLANTS OR INSTRUMENTS"

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAP NUT BECAME LOOSE POST-OPERATIVELY. CAP NUT REMAINS IMPLANTED. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY SS 6.35MM CAP NUT KWP EBI, LLC 51112

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention