BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOGUARD TR250 PTFE MEMBRANE

    MDR report key: 15069910 · Received July 20, 2022

    Report

    Report Number
    1650372-2022-00001
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    June 2, 2022
    Report Date
    July 20, 2022
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Product Code
    LYC
    UDI-DI
    00844868042020
    PMA / PMN Number
    K972278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, COMPLETE INFORMATION IS NOT AVAILABLE IN SPITE OF EFFORTS TO OBTAIN FURTHER INFORMATION FROM THE CLINICIAN. GUIDED BONE REGENERATION (GBR) PROCEDURES ARE HIGHLY TECHNIQUE SENSITIVE, AND INFECTION IS A KNOWN COMPLICATION. THERE ARE PUBLISHED PROTOCOLS OUTLINING STEPS TO TAKE IN THE CASE OF INFECTION (1). THE UNIT HAS NOT BEEN RETURNED TO DATE, SO THE DEVICE HAS NOT BEEN INSPECTED. THE LOT HISTORY WAS REVIEWED AND THE PRODUCT WAS VERIFIED TO HAVE BEEN MANUFACTURED CORRECTLY AND STERILIZED VIA A VALIDATED STERILIZATION CYCLE, AND NO DISCREPANCIES WERE FOUND. PTFE IS A BIOINERT MATERIAL. THERE ARE MANY CLINICAL FACTORS THAT COULD LEAD TO THIS EVENT, AND BASED ON THE REVIEW OF THE LOT HISTORY AND COMPLAINT TRENDING, WE DO NOT BELIEVE THIS WAS DEVICE RELATED AT THIS TIME. WE ARE SUBMITTING THIS REPORT TO BE CONSERVATIVE AND IN AN ABUNDANCE OF CAUTION. THIS DEVICE WAS SOLD AND USED IN FRANCE. 1. VROOM M, GRUNDEMANN L, GALLO P. CLINICAL CLASSIFICATION OF HEALING COMPLICATIONS AND MANAGEMENT IN GUIDED BONE REGENERATION PROCEDURES WITH A NONRESORBABLE D-PTFE MEMBRANE. INTERNATIONAL JOURNAL OF PERIODONTICS & RESTORATIVE DENTISTRY 2022;42:419-427.

    Description of Event or Problem · 0

    DOCTOR REPORTED INFECTION AT THE GRAFT SITE AND REMOVAL OF THE MEMBRANE AND BIO-BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358477 OSSEOGUARD TR250 PTFE MEMBRANE TITANIUM-REINFORCED PTFE MEMBRANE LYC OSTEOGENICS BIOMEDICAL, INC. TR250RAK-1 V2J006A 00844868042020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention