INION GTR BIODEGRADABLE SYSTEM
Received Dec 8, 2022
Report 3003407235-2022-00003 · MDR key 15937853
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
47 YR · Unknown
- Wound Dehiscence
- Erosion
- Foreign Body Reaction
- Impaired Healing
- Wound Dehiscence
- Erosion
- Foreign Body Reaction
- Impaired Healing
Narrative
Description of Event or Problem
PURPOSE OF THIS STUDY WAS TO EVALUATE WHETHER OR NOT THE USE OF A XENOGENEIC BLOCK LOADED WITH RHBMP 2 RESULTS IN SUPERIOR RADIOLOGICAL AND PROFILOMETRIC OUTCOMES COMPARED TO AN AUTOGENOUS BONE BLOCK IN RIDGE AUGMENTATION. 24 PATIENTS WERE TREATED WITH XENOGENEIC BLOCK LOADED WITH RHBMP 2 (TEST GROUP) OR AUTOGENOUS BLOCK (CONTROL GROUP). THE AUGMENTED AREA WAS COVERED WITH A NATIVE COLLAGEN MEMBRANE, WHICH WAS IMMOBILIZED BY INION GTR TACKS. IN ONE PATIENT IN THE CONTROL GROUP, THE AUGMENTATION PROCEDURE FAILED WITH THE AUTOGENOUS BONE BLOCK BEING EXPOSED 6 DAYS AFTER SURGERY. DUE TO AN INEFFECTIVE ANTISEPTIC TREATMENT, THE BLOCK HAD TO BE REMOVED AFTER 21 DAYS TO ALLOW FOR ADEQUATE WOUND HEALING. THE AUGMENTATION PROCEDURE WAS SUCCESSFUL WITH OTHER 23 PATIENTS.
Additional Manufacturer Narrative
IN THIS STUDY, INION GTR TACKS WERE USED TO IMMOBILIZE THE MEMBRANE COVERING THE AUGMENTED AREA OF EACH PATIENT. IN ONE PATIENT IN THE CONTROL GROUP, THE AUGMENTATION PROCEDURE FAILED WITH THE AUTOGENOUS BONE BLOCK BEING EXPOSED 6 DAYS AFTER SURGERY. DUE TO AN INEFFECTIVE ANTISEPTIC TREATMENT, THE BLOCK HAD TO BE REMOVED AFTER 21 DAYS TO ALLOW FOR ADEQUATE WOUND HEALING. IN THIS STUDY, THE REASON FOR THE BLOCK EXPOSURE REMAINED UNCLEAR. THE STUDY DID NOT REPORT THAT THE INION GTR TACKS IMMOBILIZING COLLAGEN MEMBRANE WOULD HAVE FAILED AND CAUSED THE EXPOSURE OF THE AUTOGENOUS BLOCK. HOWEVER, THE INION TACK MIGHT HAVE CONTRIBUTED TO THE EVENT, AS EXPLANATION FOR THE BLOCK EXPOSURE WAS NOT REPORTED IN THE STUDY. SINCE THE PATIENT WITH THE FAILED AUGMENTATION REFUSED TO UNDERGO ANOTHER SURGICAL PROCEDURE, HE WAS EXCLUDED FROM THE PRESENT STUDY. IN 23 OUT OF 24 PATIENTS ORIGINALLY INCLUDED TO THE STUDY, THE AUGMENTATION PROCEDURE WAS SUCCESSFUL.