BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPIOS EXTEND

    MDR report key: 6908791 · Received October 2, 2017

    Report

    Report Number
    2249852-2017-00015
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    September 5, 2017
    Report Date
    September 27, 2017
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPL
    UDI-DI
    00813954020556
    PMA / PMN Number
    K100156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW AND ADDITIONAL QC RESERVE SAMPLE TESTING CONFIRMS THAT THE PRODUCTION LOT MET RELEASE CRITERIA. THERE ARE NO INDICATIONS THAT THE DEVICE WOULD NOT FUNCTION AS DESIGNED.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT THE MEMBRANE DID NOT HOLD FORM AND DISINTEGRATED 2 DAYS FOLLOWING THE IMPLANTATION. NO INFORMATION WAS PROVIDED WHETHER PRIMARY CLOSURE WAS ACHIEVED AND THE CLINICIAN DID NOT REPORT ANY ADVERSE REACTIONS OR PATIENT INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686415 COPIOS EXTEND COLLAGEN DENTAL MEMBRANE V NPL COLLAGEN MATRIX, INC. 0192Z PDMU17A1 00813954020556

    Patients

    Seq Age Sex Outcome Treatment
    1