BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEPGEN P-15 FLOW

    MDR report key: 725779 · Received June 8, 2006

    Report

    Report Number
    1721411-2006-00238
    Event Type
    Injury
    Date Received
    June 8, 2006
    Date of Event
    April 14, 2006
    Report Date
    May 9, 2006
    Manufacturer
    DENTSPLY FRIADENT CERAMED
    Product Code
    NPZ
    PMA / PMN Number
    P990033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE TO OSSEOINTEGRATE AND DEVELOPMENT OF INFECTION ARE INHERENT RISKS OF THE PROCEDURE KNOWN TO DOCTOR AND PATIENT BEFORE THE PROCEDURE IS INITIATED AND ARE DEPENDENT ON MANY FACTORS INCLUDING THE PATIENT'S AGE, SEX, HEALTH, AND OCCIAL HISTORY, THE TYPE AND SIZE OF THE DEFECT BEING GRAFTED, AND GRAFT PLACEMENT TECHNIQUE. THESE RISKS ARE INCREASED IN A PATIENT THAT IS A SMOKER IN ADDITION TO THE POTENTIAL SURGICAL COMPLICATION OF ORAL-NASAL COMMUNICATION AND POOR QUALITY BONE. THOUGH PEPGEN WILL REMODEL TO BONE AT A SIMILAR RATE AS NATURAL BONE IN A PATIENT, IT IS IMPOSSIBLE TO DETERMINE THE SPECIFIC RESORPTION RATE OF ANY BONE GRAFTING MATORIAL; MATERIAL PLACED IN AN AREA OF LOW VASCULARITY AND LITTLE OSTEOGENIC POTENTIAL WILL TAKE MUCH LONGER TO REMODEL TO BONE THAN IF PLACED IN A MORE ACTIVE SITE. CONSIDERING THIS AND THE AVAILABLE INFORMATION, THIS EVENT DOES NOT APPEAR TO BE A RESULT OF A MALFUNCTION OF THE DEVICE. THE IMPLANT LOSS WILL BE REPORTED VIA ASR. THE LOT NUMBER WAS PROVIDED FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE. PLEASE REFERENCE REPORT NUMBER 1721411-2006-00237 FOR DOCUMENTATION OF THE EVENT AS IT PERTAINS TO THE PEPGEN P-15 PUTTY USED.510K # P990033

    Description of Event or Problem · 1

    INFECTION DEVELOPED AND NO OSSEOINTEGRATION WAS ACHIEVED AFTER CONCURRENT PLACEMENT OF PEPGEN P-15 FLOW, PEPGEN P-15 PUTTY, AND AN IMPLANT. AT THE TIME OF IMPLANT PLACEMENT, IT IS NOTED BY THE DOCTOR THAT THERE WAS A POSSIBLE COMMUNICATION BETWEEN THE ORAL CAVITY AND FLOOR OF THE NOSE. ADDITIONALLY, THE DOCTOR STATES THAT AT UNCOVERING, THE IMPLANT FAILED SECONDARY TO MOBILITY AND INFECTION IN THE FORM OF PERI-IMPLANTITIS AND OSTEOLYSIS. AS A RESULT, IT CAN BE PRESUMED THAT ANOTHER SURGICAL PROCEDURE WOULD BE NECESSARY TO ACHIEVE THE DESIRED RESULTS AND PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE THAT WOULD NOT BE TRIVIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEPGEN P-15 FLOW NPZ NPZ DENTSPLY FRIADENT CERAMED NA P0104096

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention XIVE 4.5X11 IMPLANT