INION GTR BIODEGRADABLE SYSTEM
Received Dec 15, 2022
Report 3003407235-2022-00004 · MDR key 15986034
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
52 YR · Unknown
- Wound Dehiscence
- Foreign Body Reaction
- Unspecified Infection
- Wound Dehiscence
- Foreign Body Reaction
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
28 PATIENTS WITH FULLY EDENTULOUS ATROPHIC MAXILLAE. IN ORDER TO SUPPORT DENTAL PROSTHESES, 15 PATIENTS RECEIVED SHORT IMPLANTS, 13 PATIENTS RECEIVED AUTOGENOUS BONE (HARVESTED FROM ILIAC CREST) AND LONG IMPLANTS. INION GTR MEMBRANE USED IN THE LATTER AUTOGENOUS BONE GROUP IN ALL PATIENTS (13). 1 PATIENT IMPLANTED WITH INION GTR MEMBRANE HAD 2 DEHISCENCES AT 2 WEEKS - INFECTION SUSPECTED - TREATED WITH ANTIBIOTICS, DEBRIDEMENT.
Description of Event or Problem
PURPOSE OF THE STUDY: TO EVALUATE WHETHER SHORT (5.0 TO 8.5 MM) DENTAL IMPLANTS COULD BE A SUITABLE ALTERNATIVE TO LONGER (AT LEAST 11.5 MM-LONG) IMPLANTS PLACED IN ATROPHIC MAXILLAE AUGMENTED WITH AUTOGENOUS BONE FOR SUPPORTING DENTAL PROSTHESES. NO. PATIENTS WITH INION GTR MEMBRANE: 13. CONTROL GROUP AND NO. OF PATIENTS: 15. TREATMENT TIME: FROM JUNE 2009 TO APRIL 2010. FOLLOW-UP TIME: 1 YEAR AFTER IMPLANT LOADING. 1 PATIENT IMPLANTED WITH INION GTR MEMBRANE HAD 2 DEHISCENCES AT 2 WEEKS - INFECTION SUSPECTED - TREATED WITH ANTIBIOTICS, DEBRIDEMENT.