BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESL PEEK SPACER

    MDR report key: 2183154 · Received July 28, 2011

    Report

    Report Number
    2242816-2011-00097
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    EBI, LLC
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS 2 OF 2 MDRS RELATING TO THE SAME REPORTED EVENT. PLEASE ALSO SEE MDR NUMBER:2242816-2011-00090.

    Additional Manufacturer Narrative · 1

    THIS IS 1 OF 2 MDRS RELATING TO THE SAME REPORTED EVENT. PLEASE ALSO SEE MDR NUMBER: 2242816-2011-00090.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE THE PHYSICIAN ATTEMPTED TO REINSERT A SPACER AT A DIFFERENT ANGLE, THE IMPLANT FRACTURED. BOTH PIECES WERE RETRIEVED. A REPLACEMENT SPACER FRACTURED ALSO WHILE TRYING TO REINSERT AT A DIFFERENT ANGLE. THE PROCEDURE WAS COMPLETED WITH BMP AND BONE, NO SPACER WAS IMPLANTED AT THAT LEVEL. 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 SPACER 13MM SPACER MQP EBI, LLC 474950

    Patients

    Seq Age Sex Outcome Treatment
    1