InjuryNPK

INION GTR MEMBRANE MBR-200

Received Feb 3, 2009

Report MW5009858 · MDR key 1304445

Device

Generic name

Gtr Membrane

Manufacturer

Inion Oy

Model number

MBR-200

Lot number

0706038

Product problems

Explanted

Patient

50 YR

Wound Dehiscence
Foreign Body Reaction
Unspecified Infection
Surgical procedure

Narrative

Description of Event or Problem

INION MEMBRANE. USED FOR MANDIBULAR BONE GRAFT AS GUIDED TISSUE REGENERATION RESORBABLE MEMBRANE. CAUSED FOREIGN BODY REACTION. NO IMPROVEMENT, IF ANYTHING PROBABLY CAUSED SOME ADDITIONAL BONE LOSS. I HAVE STOPPED USING THIS MEMBRANE, BECAUSE OF THE 5 OR 6 TIMES I HAVE USED IT EVERY PT HAS HAD WOUND BREAKDOWN &/OR INFECTION. IF YOU REQUIRE ADDITIONAL INFO REGARDING SPECIFIC PTS PLEASE CONTACT ME. DATE OF USE: 2008 - 2009. DIAGNOSIS OR REASON FOR USE: MANDIBULAR ATROPHY.