BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTOPLAST PTFE SUTURE

    MDR report key: 11475115 · Received March 12, 2021

    Report

    Report Number
    1650372-2021-00002
    Event Type
    Injury
    Date Received
    March 12, 2021
    Report Date
    March 10, 2021
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Product Code
    NBY
    UDI-DI
    D765CS0618PREM0
    PMA / PMN Number
    K072076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNITS WERE NOT RETURNED, SO THEY 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 AND THIS IS THE FIRST COMPLAINT RECEIVED BY OSTEOGENICS CONCERNING TISSUE IRRITATION/SWELLING. 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 · 1

    THE CLINICIAN STATED THAT THE TISSUE AROUND THE PTFE SUTURE BECAME SWOLLEN AND THEREFORE HAD A HIGHER TENSION ON THE FLAP. THE SUTURE HAD TO BE REMOVED EARLY AND UPON REMOVAL THE IRRITATION DISAPPEARED. THE PATIENT HEALED UPON SUTURE REMOVAL AND THEREFORE THERE WAS NO SERIOUS OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370261 CYTOPLAST PTFE SUTURE PTFE SUTURE NBY OSTEOGENICS BIOMEDICAL, INC. CS0618PREM RC06435A D765CS0618PREM0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention