BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEPGEN P-15 PUTTY

    MDR report key: 1241025 · Received November 21, 2008

    Report

    Report Number
    3006146445-2008-00131
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    August 18, 2008
    Report Date
    October 23, 2008
    Manufacturer
    DENTSPLY TULSA
    Product Code
    NPZ
    PMA / PMN Number
    P990033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE OF BONE GRAFTS TO OSSEOINTEGRATE IS AN INHERENT RISK OF THE PROCEDURE, ALTHOUGH UNCOMMON. OTHER VARIABLES, BEYOND PRODUCT NOT PERFORMING TO SPECIFICATIONS OR BEING NON-STERILE, TO CONSIDER IN A DIFFERENTIAL DIAGNOSIS WOULD BE PATIENT HEALTH AND SOCIAL HISTORY (WHICH APPEAR TO BE UNREMARKABLE), SITE PREPARATION TRAUMA (HEAT OR PRESSURE) RESULTING IN NECROSIS OR SCARRING AND FIBROSIS, INSUFFICIENT PRIMARY STABILITY (SECONDARY TO BONE QUALITY AND/OR EXCESSIVE PREPARATION OF THE OSTEOTOMY AND QUANTITY OF MAXILLARY RIDGE BELOW THE MAXILLARY SINUS) OF THE IMPLANT RESULTING IN MICRO OR MACRO MOVEMENT AND SUBSEQUENT FIBROUS INTEGRATION, INDIVIDUAL GRAFTING TECHNIQUES, AND POST-OPERATIVE COMPLICATIONS (E.G. INFECTION). FROM THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE IF THE IMPLANT, GRAFT, TECHNIQUE, PATIENT COMPLIANCE, POST-OPERATIVE COMPLICATION, ETC. WAS THE ETIOLOGY OF FAILURE. HOWEVER, BECAUSE A SECOND SURGERY WAS REQUIRED TO REMOVE AND/OR REPLACE THE IMPLANT AND GRAFT, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE IMPLANT LOSS WILL BE REPORTED VIA ASR, AS APPROPRIATE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEPGEN P-15 PUTTY AND AN UNKNOWN ALLOGRAFT MATERIAL WERE PLACED SIX MONTHS PRIOR TO IMPLANT PLACEMENT VIA A SINUS LIFT PROCEDURE. THE IMPLANT WAS LOST IN THE SINUS AND RETRIEVED TEN DAYS LATER, WITH THE DOCTOR REPORTING THAT THE "BONE WASN'T SOLID ENOUGH." IT IS NOT CLEAR IF THE GRAFT WAS INTEGRATING WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEPGEN P-15 PUTTY NPZ DENTSPLY TULSA NA 08PY012

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention ANKYLOS B9.5 IMPLANT