BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUGMENT INJECTABLE

    MDR report key: 12518282 · Received September 23, 2021

    Report

    Report Number
    3003897776-2021-00007
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    June 17, 2021
    Report Date
    September 23, 2021
    Manufacturer
    BIOMIMETIC THERAPEUTICS, LLC
    Product Code
    NOX
    UDI-DI
    10859477002140
    PMA / PMN Number
    P100006
    Removal / Correction Number
    Z-2335-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE INSPECTION OF OTHER LOTS ON THE SHELF WERE FOUND WITH THE SAME ISSUE. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A CO-MINGLING RELATED ISSUE. THE FAILURE WAS CAUSED BY TWO PARTIAL VIAL LOT BOXES (1.5ML AND 3.0ML) WERE CONSOLIDATED INTO ONE BOX. A NON-CONFORMANCE WAS OPENED IN THE LEGACY WRIGHT NCE SYSTEM AND A FIELD ACTION ASSESSMENT WAS PERFORMED. PACKAGING DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KIT HAD 1.5CC RHPDGF VIAL INSTEAD OF THE 3CC RHPDGF VIAL. THE KIT WAS MIXED AND COMBINED WITH A SECOND UNIT OF 1.5CC TO GET THE 3CC TOTAL. THIS WAS COMBINED WITH AN ADDITIONAL 3CC KIT AS THE SURGEON WANTED 6CC IN TOTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417093 AUGMENT INJECTABLE FILLER, BONE VOID, SYNTHETIC PEPTIDE NOX BIOMIMETIC THERAPEUTICS, LLC K30003010 1706343 10859477002140

    Patients

    Seq Age Sex Outcome Treatment
    1