BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOGUARD TR150 PTFE MEMBRANE

    MDR report key: 12868957 · Received November 24, 2021

    Report

    Report Number
    1650372-2021-00004
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    October 11, 2021
    Report Date
    November 19, 2021
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Product Code
    LYC
    PMA / PMN Number
    K972278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFECTION IS A KNOWN COMPLICATION OF GUIDED BONE REGENERATION PROCEDURES. THE UNIT WAS NOT RETURNED, SO THE DEVICE COULD NOT BE 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.

    Description of Event or Problem · 0

    DOCTOR REPORTED INFECTION WITH INFLAMMATION AT TOOTH SITE 45. AUGMENTATION WAS PERFORMED BEFORE IMPLANTATION ON (B)(6) 2021. REMOVAL OF STITCHES WAS ON (B)(6) 2021 AND INFECTION WAS FOUND OUT ON (B)(6) 2021. DOCTOR USES THIS METHOD WITH PUROS AND COPIOS PRODUCTS. DOCTOR BELIEVES THAT THE PTFE MEMBRANE HAS CAUSED THE INFLAMMATORY REACTION. DOCTOR PERFORMED RINSING AND PRESCRIBED MEDICAMENTS AND ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770042 OSSEOGUARD TR150 PTFE MEMBRANE TITANIUM-REINFORCED PTFE MEMBRANE LYC OSTEOGENICS BIOMEDICAL, INC. TR150AE-1 V1A009A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention