BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUGMENT INJECTABLE

    MDR report key: 12516746 · Received September 22, 2021

    Report

    Report Number
    3003897776-2021-00005
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    April 28, 2021
    Report Date
    September 22, 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
    IL, 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.

    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. NO IMPACT TO PATIENT, JUST LESS PRODUCT USED THAN PLANNED. NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413043 AUGMENT INJECTABLE FILLER, BONE VOID, SYNTHETIC PEPTIDE NOX BIOMIMETIC THERAPEUTICS, LLC K30003010 1706343 10859477002140

    Patients

    Seq Age Sex Outcome Treatment
    1