BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTOPLAST REGENTEX TITANIUM 250

    MDR report key: 7197990 · Received January 16, 2018

    Report

    Report Number
    1650372-2018-00001
    Event Type
    Injury
    Date Received
    January 16, 2018
    Report Date
    April 5, 2018
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Product Code
    LYC
    PMA / PMN Number
    K972278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, COMPLETE INFORMATION IS NOT AVAILABLE IN SPITE OF EFFORTS TO OBTAIN FURTHER INFORMATION. CONTACT WAS MADE WITH THE DENTIST; HOWEVER, THE RESPONSE TIME HAS BEEN SLOW AND THE INFORMATION RECEIVED HAS BEEN INCOMPLETE AND UNCLEAR. THE INFORMATION GIVEN IN THIS REPORT IS ALL THE INFORMATION THAT HAS BEEN OBTAINED AT THIS TIME. THIS DEVICE WAS SOLD AND USED IN (B)(6). WE ARE SUBMITTING THIS REPORT TO BE CONSERVATIVE AND IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    A SPONTANEOUS REPORT PERTAINING TO CYTOPLAST TITANIUM-REINFORCED PTFE MEMBRANE WAS RECEIVED FROM A DENTIST IN (B)(6) ON (B)(6) 2017. THE DENTIST STATED THAT HE USE A TITANIUM-REINFORCED MEMBRANE IN A BONE GRAFTING PROCEDURE AND REENTERED THE SITE AFTER 6 MONTHS. THE DENTIST STATED THAT THE SOFT TISSUE LOOKED NICE WITH NO DEHISCENCES BEFORE REOPENING THE SITE. WHEN THE FLAP WAS OPENED THERE WAS NO BONE AND THERE SEEMED TO BE AN INFECTION. THE DOCTOR ALSO STATED THAT THE MEMBRANE ITSELF SEEMED TO DISINTEGRATE. THIS HAS HAPPENED ON FOUR CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41861 CYTOPLAST REGENTEX TITANIUM 250 NON-ABSORBABLE BARRIER MEMBRANE LYC OSTEOGENICS BIOMEDICAL, INC. TI150XLK-2 A117044

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention