BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNABLAST PASTE 3CC

    MDR report key: 2410494 · Received January 9, 2012

    Report

    Report Number
    3005990499-2011-00060
    Event Type
    Injury
    Date Received
    January 9, 2012
    Date of Event
    December 8, 2011
    Report Date
    December 12, 2011
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NUN
    PMA / PMN Number
    K043573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CONTRACT MANUFACTURED FOR KEYSTONE DENTAL BY INTEGRA LIFESCIENCES. KEYSTONE DENTAL HAS AN EXCLUSIVE LICENSE TO SELL THE DYNABLAST PRODUCT FOR DENTAL APPLICATIONS FROM INTEGRA LIFESCIENCES, THE DEVELOPER OF THE PRODUCT. A REVIEW OF KEYSTONE DENTAL INC. AND INTEGRA LIFESCIENCES COMPLAINT DATABASES IDENTIFIED NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. KEYSTONE DENTAL INC AND INTEGRA LIFESCIENCS CONDUCTED A REVIEW OF THE BATCH RECORDS FOR DYNABLAST LOT 090012 WHICH INDICATED THAT THIS PRODUCT WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE PRODUCT'S RELEASE GUIDELINES. NO NONCONFORMANCES OR DEVIATIONS WERE OBSERVED. KEYSTONE DENTAL'S INVESTIGATION REVEALED THIS PT HAD A KNOWN SENSITIVITY TO THE MIACYIN ANTIBIOTICS GROUP. THE ACUTE ALLERGIC REACTION MAY HAVE BEEN CAUSED BY THE TRACES OF GENTAMICYN AND POLYMYXIN ANTIBIOTICS THAT ARE USED DURING THE PROCESSING OF THE DYNAMATRIX. IT WAS ALSO NOTED DURING THIS INVESTIGATION THAT THE PRODUCT WAS NOT USED IN ACCORDANCE WITH THE LABELING INSTRUCTIONS; THE PRODUCT WAS USED POST EXPIRATION. THERE WAS NO INDICATION THAT THE USE OF THE PRODUCT PAST ITS EXPIRATION CONTRIBUTED TO THE PT'S ALLERGIC REACTION, HOWEVER, KEYSTONE DENTAL INC HAS NOTIFIED THE CLINICIAN THAT AN EXPIRED PRODUCT WAS USED FOR THIS PROCEDURE, AND CAUTIONED THE CLINICIAN AGAINST THE USE OF PRODUCTS BEYOND THEIR EXPIRATION IN THE FUTURE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, KEYSTONE DENTAL'S CUSTOMER RELATIONS GROUP RECEIVED A CALL FROM A CUSTOMER WHO STATED HIS PT HAD AN ALLERGIC REACTION TO THE DYNABLAST PASTE 15 MINUTES FOLLOWING THE GRAFTING PROCEDURE. AS REPORTED BY THE PT'S DENTAL CLINICIAN, THE PT WAS TRANSPORTED TO THE HOSPITAL WITH AN AMBULANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNABLAST PASTE 3CC NUN KEYSTONE DENTAL 10.210.1070 090012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L| R| S