BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENOVIX GUIDED HEALING COLLAGEN MEMBRANE

    MDR report key: 6521173 · Received April 25, 2017

    Report

    Report Number
    3007702492-2017-00002
    Event Type
    Injury
    Date Received
    April 25, 2017
    Date of Event
    December 19, 2016
    Report Date
    March 29, 2017
    Manufacturer
    BIOM'UP SA
    Product Code
    NPL
    UDI-DI
    03760193181975
    PMA / PMN Number
    K103087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE - A RESORBABLE COLLAGEN DENTAL MEMBRANE - WAS ONE OF THREE DEVICES USED IN THE PROCEDURE. THE DOCTOR REMOVED THE MEMBRANE AND IMPLANT AND CLEANED THE TISSUES AT THE SITE OF THE INFECTION. THE MEMBRANE IS THE SUBJECT OF A CLASS II MEDICAL DEVICE RECALL (Z-1110-2017) WHICH WAS INITIATED APPROXIMATELY ONE MONTH AFTER THE SUBJECT PROCEDURE. THE REASON FOR INITIATING THE RECALL WAS DUE TO A STERILIZATION DOSE AUDIT FAILURE IN WHICH SUBSEQUENT INVESTIGATION IDENTIFIED A SINGLE BACTERIA TYPE REMAINING PRESENT AFTER THE LOW AUDIT DOSE EXPOSURE - BELOW THE ACTUAL STERILIZATION DOSE USED IN NORMAL PRODUCTION. THE BACTERIA IS SUSCEPTIBLE TO THE FULL IRRADIATION DOSE USED IN NORMAL PRODUCTION. RETAINED SAMPLES FROM THE SAME LOT WERE TESTED AND DETERMINED TO BE STERILE. A CULTURE OF THE INFECTION SITE WAS NOT PERFORMED THEREFORE A DEFINITIVE CONCLUSION AS TO WHETHER THE BACTERIA THAT CAUSED THE INFECTION WAS THE BACTERIA IDENTIFIED IN THE RECALL CANNOT BE REACHED. MOREOVER, IT CANNOT BE DETERMINED WHETHER THE INFECTION WAS SOLELY THE RESULT OF THE SURGICAL PROCEDURE. THUS, BECAUSE IT CANNOT BE DETERMINED WHETHER OR NOT THE DEVICE CONTRIBUTED TO THE INFECTION, OUT OF AN ABUNDANCE OF CAUTION, THE COMPANY IS REPORTING THIS EVENT. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DOCTOR REPORTED INFECTION AT TOOTH SITE 10 WHERE MEMBRANE, BONE GRAFT, AND DENTAL IMPLANT WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299892 RENOVIX GUIDED HEALING COLLAGEN MEMBRANE DENTAL MEMBRANE NPL BIOM'UP SA RENOVIX-15X25 MCG16003.133037 03760193181975

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention