INION GTR BIODEGRADABLE MEMBRANE SYSTEM
Received Dec 8, 2022
Report 3003407235-2022-00002 · MDR key 15938119
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
Unknown
- Wound Dehiscence
- Abrasion
- Erosion
- Wound Dehiscence
- Abrasion
- Erosion
Narrative
Description of Event or Problem
THIS 4-CASE STUDY OF 4 PATIENTS AIMED TO PRESENT CLINICAL CLASSIFICATION OF BONE AUGMENTATION PROCEDURE FAILURES IN THE ATROPHIC ANTERIOR MAXILLAE AND THEIR ETHTETIQUE CONSEQUENCES AND TREATMENT OPTIONS. INION GTR MEMBRANE AND TACKS WERE USED WITH ONE PATIENT IN THE CASE PRESENTATION. THIS CASE PRESENTATION FOCUSED ON SHOWCASING COMPLICATIONS. WITH ALL PATIENTS THE HEALING WAS UNEVENTFUL. ONE PATIENT HAD A PARTIAL EXPOSURE OF AN ANGLE OF THE MEMBRANE, WHICH OCCURRED AFTER FOUR MONTHS, AND WAS IMMEDIATELY TREATED AND RESOLVED WITH A LITTLE PLASTIC.
Additional Manufacturer Narrative
ONE PATIENT TREATED WITH THE INION GTR MEMBRANE AND TACKS HAD UNEVENTFUL HEALING, EXCEPT FOR A PARTIAL EXPOSURE OF AN ANGLE OF THE MEMBRANE, WHICH OCCURRED AFTER FOUR MONTHS, AND WAS IMMEDIATELY TREATED AND RESOLVED WITH A LITTLE PLASTIC. EIGHT MONTHS AFTER THE IMPLANT PLACEMENT, THE HEALING OF SCREW STAGE WAS COMPLETED. THE IMPLANTS APPEARED STABLE AND WELL OSSEOINTEGRATED, BUT THE BUCCAL PROFILE WAS STILL NOT SUFFICIENTLY THICK TO PROVIDE A GOOD ESTHETIC RESULT.