InjuryEBH
PERMADYNE PENTA L
Received Dec 22, 1998 · Event occurred Nov 26, 1998
Report 9611385-1998-00010 · MDR key 203769
Device
Generic name
Polyether Based Impression Material
Manufacturer
Espe Dental AgModel number
NACatalog number
030360
Lot number
FW0044233
Product problems
- Failure to Osseointegrate
- Other (for use when an appropriate device code cannot be identified)
Patient
UNKNOWN
- Unspecified Infection
Narrative
Description of Event or Problem
ON 11/27/1998 A DENTIST CALLED AND REPORTED AN ADVERSE EVENT INVOLVING PERMADYNE PENTA L, AN IMPRESSION MATERIAL MANUFACTURED BY ESPE. THE DENTIST DID AN IMPRESSION IN A PATIENT WHO WAS RECENTLY TREATED BY IMPLANTOLOGY. THE MATERIAL DID NOT CURE AND SOAKED INTO THE STITCHES OF THE JUST REMOVED SUTURE. AS A RESULT OF AN ACCOMPANYING INFECTION TWO IMPLANTS WERE REJECTED.