BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONNEXUS 1CC

    MDR report key: 2111027 · Received May 17, 2011

    Report

    Report Number
    2090010-2011-00009
    Event Type
    Other
    Date Received
    May 17, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 17, 2011
    Manufacturer
    INTEGRA, IRVINE
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PROD HAD BEEN IMPLANTED FOR A SINUS LIFT AT THE SITE OF A DENTAL EXTRACTION DEFECT AT THE UPPER RIGHT MOLAR WHERE THERE WAS A FACIAL PLATE DEFECT. WHEN THE DR RE-ENTERED THE SITE 4 MONTHS LATER, THE PROD WAS OBSERVED TO BE "MUSH". IT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONNEXUS 1CC NA MQV INTEGRA, IRVINE 100557

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR