MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-10-20 for PEPGEN P-15 PUTTY UNK manufactured by Dentsply Friadent Ceramed.
[537026]
It was reported that clinical mobility was present, and no osseointegration was achieved in two mandibular central incisor sites, into which implants and pepgen p-15 putty bone grafting material had been concurrently placed, approximately two months earlier. After placement, the implants were immediately temporized and adjusted to the free of contact in centric occlusion and/or centric relation, and the patient was informed "not to chew on the crowns;" although the implant was "out of function," there will still be more load on the impalnt than if it was submerged beneath the tissue or at bone level. It is not clear if the graft integrated with the surrounding vital bone, or if it also failed with the implant, although the healing time is too short to expect complete integration. 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 wouild not be trivial.
Patient Sequence No: 1, Text Type: D, B5
[7914198]
Failure to osseointegrate, while uncommon, is an inherent risk of the procedure known to doctor and patient before the procedure is initiated and is dependent on many factors including the patient's age, sex, health, and social history, the type and size of the defect being grafted, occurrence of site preparation trauma (heat or pressure), primary stability of the implant (although the doctor states the implants were placed at torque levels of 50 n/cm), and graft placement technique. 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 material; 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. From the information provided, it is not possible to determine if the implant or graft was the etiology of failure, though it does not appear that the grafting material malfunctioned. The implant losses will be reported via asr. The device was not returned for evaluation and the correct lot number is not known for retained-product testing and/or dhr review; the lot number provided was found to be invalid.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721411-2006-00469 |
| MDR Report Key | 771434 |
| Report Source | 05 |
| Date Received | 2006-10-20 |
| Date of Report | 2006-09-20 |
| Date of Event | 2006-09-12 |
| Date Mfgr Received | 2006-09-20 |
| Date Added to Maude | 2006-10-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | SUSQUEHANNA COMMERCE CENTER W. 321 W. PHILA. ST., STE 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY FRIADENT CERAMED |
| Manufacturer Street | 12860 WEST CEDAR DR SUITE 110 |
| Manufacturer City | LAKEWOOD CO 80228 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80228 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEPGEN P-15 PUTTY |
| Generic Name | NFZ |
| Product Code | NFZ |
| Date Received | 2006-10-20 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | 031018016A |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 759218 |
| Manufacturer | DENTSPLY FRIADENT CERAMED |
| Manufacturer Address | * LAKEWOOD CO * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-10-20 |