InjuryNPZ
PEPGEN P-15
Received Jan 26, 2006
Report 1721411-2005-00539 · MDR key 668245
Device
Generic name
Bone Grafting Material
Manufacturer
Dentsply Friadent CeramedModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Failure to Osseointegrate
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
NO OSSEOINTEGRATION WAS ACHIEVED AFTER CONCURRENT PLACEMENT OF PEPGEN P-15 BONE GRAFTING MATERIAL, PERIOGLAS, AND AN IMPLANT. 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 WOULD NOT BE TRIVIAL.