BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VUELOCK STANDARD IMPLANT KIT

    MDR report key: 2183499 · Received July 29, 2011

    Report

    Report Number
    2242816-2011-00091
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    EBI, LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS 2 OF 2 MDRS RELATED TO THIS EVENT. PLEASE SEE MDR NUMBER: 2242816-2011-00086 SUPP 1.

    Additional Manufacturer Narrative · 1

    THIS MDR IS 2 OF 2 MDRS RELATING TO THE SAME REPORTED EVENT. PLEASE ALSO SEE MDR:2242816-2011-00086.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE PROCEDURE, THE INNER SCREW SLEEVE BROKE OFF INTO THE SCREW AS THE SURGEON WAS SCREWING IT IN. THE SCREW WAS REMOVED AND REPLACED. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VUELOCK STANDARD IMPLANT KIT 5.0X14MM SELF TAPING SCREW KWQ EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1