InjuryNPZ
PEPGEN P-15 PUTTY
Received Nov 2, 2005 · Event occurred Sep 25, 2005
Report 1721411-2005-00446 · MDR key 644346
Device
Generic name
Bone Grafting Maerial
Manufacturer
Dentsply Friadent CeramedModel number
NACatalog number
99U200-005
Lot number
05P1030
Product problems
- Failure to Osseointegrate
Patient
61 YR
- Failure of Implant
- Surgical procedure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT NO OSSEOINTEGRATION WAS ACHIEVED AFTER PLACEMENT OF PEPGEN P-15 PUTTY BONE GRAFTING MATERIAL AT THE TIME OF IMPLANT PLACEMENT. THE IMPLANT WAS IN PLACE FOR APPROX 2.5 MONTHS. AS A RESULT, ANOTHER SURGICAL PROCEDURE WAS NECESSARY TO ACHIEVE THE DESIRED RESULTS AND PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE THAT WOULD NOT BE TRIVIAL.