BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSTEOSELECT DBM PUTTY

    MDR report key: 3012025 · Received March 15, 2013

    Report

    Report Number
    3005168462-2013-00006
    Event Type
    Other
    Date Received
    March 15, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BACTERIN INTERNATIONAL, INC.
    Product Code
    MQV
    PMA / PMN Number
    K091321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS IDENTIFIED AND REPORTED BY FDA INSPECTORS DURING A ROUTINE INSPECTION OF BACTERIN IN 2012.

    Description of Event or Problem · 1

    ENDOTOXIN TESTING ON BACTERIN'S OSTEOSELECT DBM PUTTY IS PERFORMED BY AN INDEPENDENT THIRD PARTY FACILITY IN ACCORDANCE WITH A VALIDATED ASSAY. BACTERIN HAD DISCUSSED A RE-TESTING OPTION WITH THE TESTING FACILITY THAT BACTERIN CONSIDERED TO BE CONSISTENT WITH THE THEN ACTIVE FDA'S 1987 GUIDANCE ON LAL TESTING FOR ENDOTOXINS (GUIDELINE ON VALIDATION OF THE LIMULUS AMEBOCYTE LYSATE TEST AS AN END-PRODUCT ENDOTOXIN TEST FOR HUMAN AND ANIMAL PARENTERAL DRUGS, BIOLOGICAL PRODUCTS, AND MEDICAL DEVICES). BACTERIN ADOPTED THIS RETESTING POLICY ON (B)(6) 2011. IN THE EVENT OF AN INITIAL ENDOTOXIN LEVEL FAILURE, TWO SUCCESSIVE ASSESSMENTS ON THE SAME SAMPLE COULD BE PERFORMED. IF THE TWO SUCCESSIVE TESTS PASSED, THE INITIAL FAILED ASSESSMENT WOULD BE CONSIDERED INVALID AND THE SAMPLE DEEMED ACCEPTABLE. AFTER THE (B)(6) 2011, WITHDRAWAL OF THE 1987 GUIDANCE DOCUMENT, BACTERIN'S RETESTING PROCEDURE WAS NOT VALIDATED PRIOR TO ACCEPTANCE AND IS ASSOCIATED WITH AN OBSERVATION IN FDA WARNING LETTER SEA13-10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110110 OSTEOSELECT DBM PUTTY DEMINERALIZED BONE MATRIX MQV BACTERIN INTERNATIONAL, INC. SEE ATTACHED SEE ATTACHED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA