BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYSTON CURVE SPACER SYSTEM AND INSTRUMENTS

    MDR report key: 2489192 · Received March 13, 2012

    Report

    Report Number
    0002242816-2012-00023
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    February 28, 2012
    Report Date
    February 28, 2012
    Manufacturer
    EBI, LLC.
    Product Code
    BZD
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PROCEDURE WAS DELAYED OVER 30 MINUTES DUE TO FOREIGN MATTER FOUND ON THE TRIAL INSERTER. OPERATING AREA WAS REPROCESSED AT THAT TIME. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYSTON CURVE SPACER SYSTEM AND INSTRUMENTS ZYSTON CURVE TRIAL BZD EBI, LLC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other