BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTOPLAST TI-250 TITANIUM-REINFORCED MEMBRANE

    MDR report key: 3032831 · Received March 7, 2013

    Report

    Report Number
    1650372-2013-00001
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 17, 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. 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. 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)(4) 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)FEMALE PRESENTING WITH ACQUIRED LOSS OF TEETH AND RIDGE ATROPHY. TWO NOBEL REPLACE TAPERED GROOVY IMPLANTS WERE PLACED SIMULTANEOUS TO A PARTICULATE BONE GRAFT USING MINEROSS ALLOGRAFT; THE GRAFT WAS COVERED WITH A CYTOPLAST TI-250 POSTERIOR SINGLE PTFE MEMBRANE. ON THE DAY OF SURGERY, THE PATIENT WAS PRESCRIBED AMPICILLIN 2G I.V. PRE-OP, PERCOCET 7.5/500, AND PERIDEX BID X 14 DAYS. THE PATIENT WAS ALSO REPORTED TO BE TAKING MOBIC AND LYSTEDA - NO DOSES REPORTED. THE DENTIST REPORTED THAT THE MEMBRANE CAUSED GINGIVAL INFLAMMATION AND BECAME INFECTED WITHIN TWO WEEKS AFTER PLACEMENT OVER THE TWO IMPLANTS AND ALLOGRAFT BONE GRAFT; HOWEVER, ACCORDING TO THE DENTIST'S SURGICAL ASSISTANT, THE MEMBRANE WAS LEFT IN PLACE FOR A TOTAL OF 36 DAYS. THE DENTIST REPORTED THAT THE MEMBRANE HAD TO BE REMOVED, THE BONE GRAFT WAS LOST, AND IMPLANT THREADS WERE EXPOSED AND CANNOT BE REGAINED. THE DENTIST NOTED THAT THE RISK OF IMPLANT LOSS IS HIGH. THE DENTIST REPORTED THAT IN HIS OPINION, THERE WERE NO CONTRIBUTING PATIENT-RELATED FACTORS OR ANY CONTRIBUTING LOCAL FACTORS. ACCORDING TO THE DENTIST'S SURGICAL ASSISTANT, FOLLOWING REMOVAL OF THE MEMBRANE, THE SITE WAS LEFT TO HEAL; AN ATTEMPT WILL BE MADE TO RESTORE THE IMPLANT IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98454 CYTOPLAST TI-250 TITANIUM-REINFORCED MEMBRANE LYC OSTEOGENICS BIOMEDICAL, INC. TI250PS-2 47123

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention MINEROSS BONE| PERIDEX BID (3/DAY)| MOBIC - DAILY BASIS| AMPICILLIN (2G I.V. PRE-OP)| PERCOCET (7.5/500)| LYSTEDA - DAILY BASIS