BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AUGMENT

    MDR report key: 24907018 · Received April 17, 2026

    Report

    Report Number
    3003897776-2026-00134
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 17, 2026
    Manufacturer
    BIOMIMETIC THERAPEUTICS, LLC
    Product Code
    NOX
    PMA / PMN Number
    P100006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 BECAME AWARE OF A LITERATURE PUBLISHED BY THE UC DAVIS MEDICAL CENTER OF SACRAMENTO, CA. THE TITLE OF THIS REPORT IS ¿PROSPECTIVE EVALUATION OF RATE OF HINDFOOT/ANKLE FUSION WITH AUGMENT INJECTABLE BONE GRAFT ¿, PUBLISHED IN FEBRUARY 2024, WHICH IS ASSOCIATED WITH THE STRYKER AUGMENT® BONE GRAFT AND INJECTABLE SYSTEM. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND AT THIS TIME NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT: FAILURE TO FUSE RESULTING IN A REVISION IN 1 CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967208 UNKNOWN AUGMENT FILLER, BONE VOID, SYNTHETIC PEPTIDE NOX BIOMIMETIC THERAPEUTICS, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention