BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESL PEEK OPTIMA IMPLANTS

    MDR report key: 1823821 · Received September 2, 2010

    Report

    Report Number
    2242816-2010-00118
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 19, 2010
    Manufacturer
    EBI, LLC
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPACER WAS STRIPPED WHILE HAVING BEEN OVER TIGHTENED.PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESL PEEK OPTIMA IMPLANTS 14MMX25MM ESL PEEK SPACER MQP EBI, LLC 237030

    Patients

    Seq Age Sex Outcome Treatment
    1