BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEPGEN P-15 PUTTY

    MDR report key: 1040236 · Received May 7, 2008

    Report

    Report Number
    1721411-2008-00038
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 7, 2008
    Manufacturer
    DENTSPLY TULSA
    Product Code
    NPZ
    PMA / PMN Number
    P99033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE OF BONE GRAFTS TO OSSEOINTEGRATE IS AN INHERENT RISK OF PROCEDURE, ALTHOUGH UNCOMMON. OTHER VARIABLES, BEYOND PROD NOT PERFORMING TO SPECS OR BEING NON-STERILE, TO CONSIDER IN A DIFFERENTIAL DIAGNOSIS WOULD BE PT 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 AN/DOR 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 COMPLICATION (E.G. INFECTION). FROM THE INFO PROVIDED, IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE IF THE IMPLANT, GRAFT TECHNIQUE, PT 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. THE IMPLANT LOSS WILL BE REPORTED VIA ASR, AS APPROPRIATE. THE DEVICE WAS NOT RETURNED FOR EVAL AND THE LOT # WAS NOT PROVIDED FOR RETAINED-PROD TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEPGEN P-15 PUTTY WAS USED SIMULTANEOUSLY WITH IMPLANT PLACEMENT IN THE LEFT POSTERIOR MANDIBLE WITH BONE QUALITY TYPE II AND FAIR ORAL HYGIENE. THE OSTEOTOMY WAS PREPARED VIA DRILLING AND HEALING WAS SUBGINGIVAL. THE IMPLANT DID NOT OSSEOINTEGRATE AND HAD SIGNS OF MOBILITY AND INFECTION UPON EXPLANTATION DURING HEALING APPROX EIGHTEEN WEEKS POST-PLACEMENT. IT IS NOT CLEAR IF THE GRAFT WAS INTEGRATING WITH THE SURROUNDING VITAL BONE OR IF IT FAILED WITH THE IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention ANKYLOS B9.5 IMPLANT