BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLAGEN PLUG-HELIPLUG

    MDR report key: 3935897 · Received June 20, 2014

    Report

    Report Number
    2523190-2014-00044
    Event Type
    Other
    Date Received
    June 20, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 6, 2014
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    LPG
    PMA / PMN Number
    P840062
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    ON (B)(6) 2014, AN INITIAL REPORT SPECIFIED THE PT RECEIVED OSSIF-I-SEM (OSSIF-I-MINERALIZED CORTICAL/CANCELLOUS ALLOGRAFT BOWL) SMALL PARTICLE BONE GRAFT AND HELIPLUG. ON AN UNSPECIFIED DATE THE PT CAME DOWN WITH PNEUMONIA AFTER THE PROCEDURE. THE PERIODONTIST DID NOT KNOW IF PNEUMONIA WAS OR WAS NOT RELATED TO THE OSSIF-I, BUT COULDN'T SAY ONE WAY OR THE OTHER FOR SURE. ON (B)(6) 2014 CUSTOMER REPORTS PROCEDURE WAS ON (B)(6) 2014 AND PNEUMONIA EVENT DIAGNOSED AT ER, ANTIBIOTICS PRESCRIBED AND PT IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364306 COLLAGEN PLUG-HELIPLUG M54-ORAL SURGERY LPG INTEGRA YORK, PA INC. 1125141

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LUITPOLD PHARMACEUTICALS INC OSSIF-I,| BOWL-SMALL PARTICLE BONE GRAFT| MINERALIZED CORTICAL/CANCELLOUS ALLOGRAFT,