BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTOPLAST TITANIUM-REINFORCED PTFE MEMBRANE

    MDR report key: 4761794 · Received May 8, 2015

    Report

    Report Number
    1650372-2015-00002
    Event Type
    Injury
    Date Received
    May 8, 2015
    Report Date
    May 7, 2015
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Product Code
    LYC
    PMA / PMN Number
    K972278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, COMPLETE INFO IS NOT AVAILABLE IN SPITE OF EFFORTS TO OBTAIN FURTHER INFO. CONTACT WAS MADE WITH THE DENTIST; HOWEVER, HE WAS UNWILLING TO COOPERATE OR PROVIDE ADDITIONAL INFO. 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". THE AUTHORS WENT ON TO DISCUSS THAT "NOWADAYS, IT CAN BE ASSUMED THAT MEMBRANE EXPOSURE IS A PREDICTABLE COMPLICATION". FURTHER THERE ARE RECOGNIZED PROTOCOLS AND PRACTICES FOR CLASSIFYING AND DEALING WITH MEMBRANE EXPOSURES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES. THIS IS THE FIRST COMPLAINT FROM THIS LOT OF (B)(4) DEVICES. THE DEVICE WAS NOT RETURNED FOR EVALUATION OR TESTING. WE ARE SUBMITTING THIS REPORT TO BE CONSERVATIVE AND IN AN ABUNDANCE OF CAUTION. FONTANA F, MASHERA E, ROCCHIETTA I, SIMION M. CLINICAL CLASSIFICATION OF COMPLICATIONS IN GUIDED BONE REGENERATION PROCEDURES BY MEANS OF A NONRESORBABLE MEMBRANE. INTERNATION JOURNAL OF PERIODONTICS AND RESTORATIVE DENTISTRY 2011; 31: 265-273.

    Description of Event or Problem · 1

    A SPONTANEOUS REPORT PERTAINING TO CYTOPLAST TITANIUM-REINFORCED PTFE MEMBRANE WAS RECEIVED FROM A DENTIST ON (B)(6) 2015. THE DENTIST STATED THAT HE USED A TITANIUM-REINFORCED BUCCAL MEMBRANE IN A BONE GRAFTING PROCEDURE AND THE CAUSE ENDED IN EARLY MEMBRANE EXPOSURE. THE DENTIST CLAIMED THAT BACTERIA ON THE MEMBRANE SEEPED DOWN BETWEEN THE PERIOSTEUM AND THE MEMBRANE AND CAUSED AN INFECTION. THE MEMBRANE WAS REMOVE PRE-MATURELY AND THE GRAFT FAILED. THE DENTIST STATED THAT HE USED MINEROSS ALLOGRAFT UNDER THE MEMBRANE AND CLOSED THE GRAFT SITE WITH CYTOPLAST PTFE SUTURE. THE DENTIST STATED THAT WHEN THE PATIENT LEFT THE OFFICE, PRIMARY CLOSURE WAS OBSERVED. THE PATIENT RETURNED AND HE REMOVED THE SUTURES IN ROUGHLY TWO WEEKS. SHORTLY AFTER THE SUTURES WERE REMOVED, THE MEMBRANE BECAME EXPOSED AT 2-4 WEEKS POST-OP. THE DENTIST STATED THAT WHEN THE PATIENT CAME IN WITH AN EXPOSED MEMBRANE HE REMOVED THE EXPOSED PORTION OF THE MEMBRANE AND AT THAT POINT HE NOTICED INFECTION. WHEN THE INFECTION WAS NOTICED HE CLEANED OUT THE SITE AND REMOVED THE REMAINING BONE GRAFT MATERIAL AND MEMBRANE. NO ADDITIONAL RELEVANT CLINICAL INFO WAS MADE AVAILABLE REGARDING EITHER THE PATIENT'S MEDICAL HISTORY OR THE TREATMENT. THE DENTIST STATED THAT THE SAME SCENARIO OCCURRED IN 3 OTHER PATIENTS. NO OTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304739 CYTOPLAST TITANIUM-REINFORCED PTFE MEMBRANE DENTAL BARRIER MEMBRANE LYC OSTEOGENICS BIOMEDICAL, INC. TI250BL-2 87151

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MINEROSS ALLOGRAFT| CYTOPLAST PTFE SUTURE