BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTOPLAST TITANIUM-REINFORCED PTFE MEMBRANE

    MDR report key: 4530313 · Received February 18, 2015

    Report

    Report Number
    1650372-2015-00001
    Event Type
    Injury
    Date Received
    February 18, 2015
    Date of Event
    June 2, 2014
    Report Date
    September 10, 2014
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Product Code
    LYC
    PMA / PMN Number
    K972278
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN PROPERLY PLACED, THE TITANIUM STRUTS ARE DESIGNED TO LAY PASSIVELY AND DO NOT HAVE THE POTENTIAL TO SPONTANEOUSLY PERFORATE TISSUE.

    Description of Event or Problem · 1

    A SPONTANEOUS REPORT PERTAINING TO CYTOPLAST TITANIUM-REINFORCED PTFE MEMBRANE WAS RECEIVED FROM A DENTIST ON (B)(6) 2014. THE PT WAS A (B)(6) YR OLD FEMALE PRESENTING WITH AN IRRESTORABLE TOOTH. TOOTH #18 WAS EXTRACTED AND A MINEROSS ALLOGRAFT (2.5 CC) WAS PLACED. A CYTOPLAST TI-250 BUCCAL PTFE MEMBRANE WAS THEN TRIMMED AND PLACED. PRIMARY CLOSURE WAS NOT ACHIEVED. THE PT WAS PRESCRIBED AMOXICILLIN 500 MG TID X 7 DAYS THE DAY OF SURGERY. THE PT HAD BEEN DIAGNOSED WITH HIGH BLOOD PRESSURE IN THE PAST, BUT WAS TAKING MEDICINE TO CONTROL THIS. THE DENTIST DID NOT REPORT WHAT MEDICINE WAS BEING TAKEN FOR THE HIGH BLOOD PRESSURE. THE DENTIST REPORTED THAT THE PT CALLED AND COMPLAINED OF DISCOMFORT 12 DAYS AFTER THE INITIAL PROCEDURE. THE DENTIST SAW THE PT THIS DAY AND OBSERVED THE TITANIUM-STRUT FROM THE MEMBRANE AND BECOME DELAMINATED FROM THE MEMBRANE AND WAS NOW POKING THROUGH THE LINGUAL SOFT TISSUE. THIS WAS CAUSING THE STRUT TO RUB AGAINST THE TONGUE AND CUT THE TONGUE. THE DENTIST REMOVED THE MEMBRANE AT THIS POINT AND REPORTED THAT A LARGE PORTION OF THE MINEROSS BONE GRAFT WAS LOST. THE DENTIST REPORTED THAT THE SOFT TISSUE AND TONGUE SUBSEQUENTLY HEALED ON THEIR OWN WITH NO OTHER REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115413 CYTOPLAST TITANIUM-REINFORCED PTFE MEMBRANE DENTAL BARRIER MEMBRANE LYC OSTEOGENICS BIOMEDICAL, INC. TI250BL-1 8771

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention AMOXICILLIN (500MG, T1DX7DAYS)| MINEROSS BONE (2.5CC)