PEPGEN P-15
Received Apr 15, 2005 · Event occurred Jan 14, 2004
Report 1721411-2005-00114 · MDR key 591828
Device
Generic name
Bone Grafting Material
Manufacturer
Dentsply Friadent CeramedModel number
NACatalog number
99U000-102
Lot number
D2C3191N
Product problems
- Device remains implanted
- Failure to Osseointegrate
Patient
UNKNOWN
- Surgical procedure, additional
Narrative
Description of Event or Problem
NO OSSEOINTEGRATION WAS ACHIEVED APRPOXIMATELY 3.5 YEARS AFTER PLACEMENT OF PEPGON 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.
Description of Event or Problem
IT WAS REPORTED THAT IMPLANTS PLACED AT TWO SITES FAILED APPROXIMATELY THREE MONTHS AFTER PLACEMENT. THE IMPLANTS WERE PLACED APPROXIMATELY FOUR MONTHS AFTER PLACEMENT OF THE GRAFTING MATERIAL.