BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONNEXUS 1CC

    MDR report key: 2111210 · Received May 26, 2011

    Report

    Report Number
    2090010-2011-00008
    Event Type
    Other
    Date Received
    May 26, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    INTEGRA, IRVINE
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE COULD NOT BE DETERMINED. SITES GRAFTED WITH ACCELL CONNEXUS SHOULD BE ALLOWED TO HEAL APPROX 6 MONTHS PRIOR TO IMPLANT PLACEMENT. ACCELL CONNEXUS IS SUITABLE FOR DRILLING AFTER HEALING OF THE OSSEOUS DEFECT. THERE MAY BE A POSSIBILITY THAT THE DENTAL IMPLANT POST WAS INSERTED PREMATURELY IN THE SOCKET CAVITY, NOT ALLOWING THE RECOMMENDED TIME FOR DBM PUTTY TO GROW BONE. FAILURE ANALYSIS OF THE ACTUAL PRODUCT USED WAS NOT POSSIBLE SINCE THE PRODUCT WAS IMPLANTED. THE PRODUCT UNITS OF THE SAME LOT 100557 THAT WERE RETURNED FROM THE CUSTOMER WERE INSPECTED AND APPEARED TO BE UNIFORM IN SHAPE, COLOR, AND TEXTURE. A RETAIN SAMPLE WAS ALSO INSPECTED AND WAS IN GOOD CONDITION. THE REVIEW OF THE MFG RECORDS, STERILIZATION RECORDS, DEMINERALIZATION RECORDS, COTTON RECORDS, AND DONOR RECORDS INDICATED THERE WERE NO ISSUES RELATED TO THE PROCESSING OF THE PRODUCT. THE ROOT CAUSE COULD NOT BE DETERMINED. SITES GRAFTED WITH ACCELL CONNEXUS SHOULD BE ALLOWED TO HEAL APPROX 6 MONTHS PRIOR TO IMPLANT PLACEMENT. ACCELL CONNEXUS IS SUITABLE FOR DRILLING AFTER HEALING OF THE OSSEOUS DEFECT. THERE MAY BE A POSSIBILITY THAT THE DENTAL IMPLANT POST WAS INSERTED PREMATURELY IN THE SOCKET CAVITY, NOT ALLOWING THE RECOMMENDED TIME FOR DBM PUTTY TO GROW BONE. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT A DENTAL PT HAD A SINUS LIFT, HAD INFECTION. DYNABLAST PUTTY AND ACCELL HAD BEEN IMPLANTED. LATER THE PRODUCT WAS DESCRIBED AS HAVING "TURNED TO MUSH." IT WAS EXPLANTED. INTEGRA HAS REQUESTED ADD'L CLINICAL INFO.

    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 DYNABLAST PUTTY