BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AUGMENT CASE #10

    MDR report key: 24889072 · Received April 15, 2026

    Report

    Report Number
    3003897776-2026-00132
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 15, 2026
    Manufacturer
    BIOMIMETIC THERAPEUTICS, LLC
    Product Code
    NOX
    PMA / PMN Number
    P100006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED SAFETY PROFILE OF AUGMENT® BONE GRAFT AND INJECTABLE IN MIDFOOT FUSION PROCEDURES: A RETROSPECTIVE COMPARATIVE COHORT STUDY UTILIZING A US HEALTHCARE DATABASE THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF AUGMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN JULY 01, 2016 - SEPTEMBER 30, 2022. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: WOUND DEHISCENCE IN 11 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953081 UNKNOWN AUGMENT CASE #10 FILLER, BONE VOID, SYNTHETIC PEPTIDE NOX BIOMIMETIC THERAPEUTICS, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other