BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTOPLAST REGENTEX TITANIUM 250

    MDR report key: 8007678 · Received October 25, 2018

    Report

    Report Number
    1650372-2018-00002
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    July 20, 2018
    Report Date
    October 25, 2018
    Manufacturer
    OSTEOGENICS IOMEDICAL, INC.
    Product Code
    LYC
    PMA / PMN Number
    K972278
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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." 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, AND THE DEVICE WAS STERILIZED CORRECTLY. THIS IS THE FIRST COMPLAINT FROM THIS LOT OF 99 DEVICES. THIS DEVICE WAS SOLD AND USED IN GERMANY. 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. INTERNATIONAL JOURNAL OF PERIODONTICS AND RESTORATIVE DENTISTRY 2011;31:265-273.

    Description of Event or Problem · 1

    A GUIDED BONE REGENERATION PROCEDURE WAS PERFORMED ON A PATIENT ALONG WITH SIMULTANEOUS PLACING OF A DENTAL IMPLANT IN POSITION 46 (EDENTULOUS SPACE)WITH NON-OPTIMAL BONE WIDTH. AUTOGENOUS BONE WAS USED AND A TI150BL MEMBRANE WAS PLACED. THE MEMBRANE WAS NOT TRIMMED, AND WAS FIXED WITH PINS IN THE VESTIBULAR AND LINGUAL. THE SITE WAS CLOSED WITH TWO-LAYERS OF SUTURE. ANTIBIOTIC THERAPY WAS GIVEN AND THERE WAS POST-OPERATIVE SWELLING. 3 WEEKS LATER, THE SUTURE WAS REMOVED AND THERE WAS NO IRRITATION. 4 WEEKS LATER, THERE WAS A SMALL LINGUAL DEHISCENCE WITH EXUDATE SECRETION. BROAD SPECTRUM ANTIBIOTIC THERAPY WAS GIVEN. 3 MONTHS LATER, THE MEMBRANE WAS REMOVED DUE TO "PERIMANDIBULAR INFILTRATE (ALMOST ABSCESS)" AND THE MEMBRANE DELAMINATED IN THE REGION OF DEHISCENCE. THE IMPLANT STAYED IN-SITU AND THE BONE REGENERATION WAS SUCCESSFUL DESPITE THE DEHISCENCE AND ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844815 CYTOPLAST REGENTEX TITANIUM 250 NON-ABSORBABLE BARRIER MEMBRANE LYC OSTEOGENICS IOMEDICAL, INC. TI150BL-2 A087073

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention