PEPGEN P-15
Received Apr 15, 2005 · Event occurred Mar 17, 2005
Report 1721411-2005-00115 · MDR key 591830
Device
Generic name
Bone Grafting Material
Manufacturer
Dentsply Friadent CeramedModel number
NACatalog number
99U000-102
Lot number
03C3175
Product problems
- Device remains implanted
- Failure to Osseointegrate
Patient
UNKNOWN
- Surgical procedure, additional
Narrative
Description of Event or Problem
IT WAS REPORTED THAT TWO IMPLANT SITES CONTAINED UNREASORBED PARTICULES APPROXIMATELY EIGHT MONTHS AFTER PLACEMENT OF PEPGEN P-15 BONE GRAFTING MATERIAL. AS ARESULT, THE DOCTOR ELECTED TO PLACE THE IMPLANT.
Description of Event or Problem
NO OSSEOINTEGRATION WAS ACHIEVED APPROXIMATELY 3.5 YEARS AFTER PLACEMENT OF PEPGEN BONE GRAFTING MATERIAL, AN EVENT THAT NECESSITATED ANOTHER SURGICAL PROCEDURE TO ACHIEVE THE DESIRED RESULTS AND PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. IT IS UNCLEAR WHETHER THE GRAFTING MATERIAL, IMPLANT, OR PATIENT CONDITION CAUSED OR CONTRIBUTED TO THE EVENT OR IF THE GRAFTING MATERIAL AND IMPLANT WERE PLACED CONCURRENTLY.