BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTOPLAST TI-250 TITANIUM-REINFORCED MEMBRANE

    MDR report key: 3032832 · Received March 7, 2013

    Report

    Report Number
    1650372-2013-00002
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 7, 2013
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Product Code
    LYC
    PMA / PMN Number
    K972278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    GUIDED BONE REGENERATION (GBR) PROCEDURES ARE HIGHLY TECHNIQUE SENSITIVE, AND DEHISCENCE IS A WELL PUBLISHED COMPLICATION. IN ONE PEER-REVIEWED PUBLISHED PAPER STUDYING THE CLINICAL CLASSIFICATION OF COMPLICATIONS IN GBR PROCEDURES UTILIZING NON-RESORBABLE MEMBRANES, THE AUTHORS STATE THAT "MEMBRANE EXPOSURE IS GENERALLY CONSIDERED THE MOST COMMON DRAWBACK OF GBR PROCEDURES." NUMBER ONE, THE AUTHORS WENT ON TO DISCUSS THAT "NOWADAYS, IT CAN BE ASSUMED THAT MEMBRANE EXPOSURE IS A 'PREDICTABLE' COMPLICATION." NUMBER ONE, FURTHER, THERE ARE RECOGNIZED PROTOCOLS AND PRACTICES FOR CLASSIFYING AND DEALING WITH MEMBRANE EXPOSURES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION OR TESTING. WE ARE SUBMITTING THIS REPORT TO BE CONSERVATIVE AND IN AN ABUNDANCE OF CAUTION. NUMBER ONE, FONTANA F, MASCHERA E, ROCCHIETTA I, SIMION M. CLINICAL CLASSIFICATION OF COMPLICATIONS IN GUIDED BONE REGENERATION PROCEDURES BY MEANS OF A NONRESORBABLE MEMBRANE. INTERNATIONAL JOURNAL OF PERIODONTICS AND RESTORATIVE DENTISTRY 2011; 31:265-273.

    Description of Event or Problem · 1

    A SPONTANEOUS REPORT PERTAINING TO CYTOPLAST TI-250 TITANIUM-REINFORCED MEMBRANE WAS RECEIVED FROM A DENTIST ON (B)(6) 2013. A CUSTOMER FEEDBACK FORM WAS SENT TO THE DENTIST TO OBTAIN ADDITIONAL INFORMATION: THE COMPLETED FORM WAS RECEIVED BY THE COMPANY ON (B)(6) 2013. FOLLOWING REQUESTS BY THE COMPANY FOR ADDITIONAL INFORMATION, THE DENTIST'S SURGICAL ASSISTANT PROVIDED ADDITIONAL INFORMATION ON (B)(4) 2013. THE PATIENT WAS A (B)(6) MALE PRESENTING WITH ANODONTIA AND ATROPHY OF THE EDENTULOUS ALVEOLAR RIDGE. A MINEROSS ALLOGRAFT (0.5CC) WAS PLACED AND COVERED WITH A CYTOPAST TI-250 ANTERIOR NARROW PTFE MEMBRANE. THREE DAYS PRIOR TO SURGERY, THE PATIENT WAS PRESCRIBED TO START CLINDAMYCIN 300 MG QID X 10 DAYS AND PERIDEX BID X 14 DAYS. THE PATIENT WAS PRESCRIBED PERCOCET 5/325 ON THE DAY OF SURGERY. THE PATIENT WAS NOT REPORTED TO BE TAKING ANY OTHER MEDICATION. THE DENTIST REPORTED THAT THERE WAS SEVERE GINGIVAL INFLAMMATION AND WIDE WOUND DEHISCENCE; ACCORDING TO THE DENTIST'S SURGICAL ASSISTANT, THIS WAS NOTED 11 DAYS AFTER INITIAL GRAFT PROCEDURE, AND THE MEMBRANE EVENTUALLY REMOVED 17 DAYS LATER. THE MINEROSS ALLOGRAFT BONE GRAFT WAS LOST AT THE SUPERIOR ASPECT OF THE RIDGE. THE DENTIST REPORTED THAT THE GINGIVAL TISSUES EXHIBITED POOR HEALING WITH THE MEMBRANE IN PLACE. THE COMPANY WAS UNABLE TO OBTAIN INFORMATION ON ANY CONTRIBUTING PATIENT-RELATED FACTORS OR ANY CONTRIBUTING LOCAL FACTORS. ACCORDING TO THE DENTIST'S SURGICAL ASSISTANT, FOLLOWING REMOVAL OF THE MEMBRANE, THE PATIENT IS HEALING. FURTHER TREATMENT PLANS WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98346 CYTOPLAST TI-250 TITANIUM-REINFORCED MEMBRANE LYC OSTEOGENICS BIOMEDICAL, INC. TI250ANL-2 10722

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention PERIDEX (14 DAYS)| CLINDAMYCIN (300 MG X 40)| MINEROSS BONE (.5CC)| PERCOCET (5/325, 4 QID X 10)