INION GTR BIODEGRADABLE MEMBRANE SYSTEM

Description of Event or Problem

DURING A POSTMARKETING CLINICAL STUDY, IN PATIENT, RANDOMISED TO THE INION MEMBRANE, THE INVESTIGATOR RECORDED THAT AT THE 6-MONTH FOLLOW-UP, THE SOFT TISSUE WAS RED AND SWOLLEN AND THE BONE AUGMENTATION WAS GONE. THE DEFECT WAS BIGGER THAN AT PRE-PROCEDURE. INVASIVE INTERVENTION WAS REQUIRED: A BIOPSY WAS PERFORMED, THE IMPLANT SITE WAS RINSED, NEW BONE AUGMENTATION WAS PERFORMED AND A NEW MEMBRANE (BIO-GIDE) WAS PLACED. THE IMPLANT WAS STABLE, WITH NO INFECTION. THE EVENT WAS REPORTED TO BE MILD, PROBABLY RELATED TO THE DEVICE AND UNLIKELY TO BE RELATED TO THE PROCEDURE. IT WAS ONGOING WHEN THE REPORT WAS COMPLETED.

Additional Manufacturer Narrative

EVALUATION: NO DEVICE EVALUATION PERFORMED; SINGLE INCIDENT. THE INION GTR MEMBRANE WAS USED IN A DENTAL GUIDED BONE REGENERATION PROCEDURE TO COVER A BONE DEFECT FILLED WITH BOVINE ORIGIN BIOOSS XENOGRAFT BONE VOID FILLER MATERIAL. SIX MONTHS POSTOPERATIVELY, THE SOFT TISSUE WAS RED AND SWOLLEN AND THE BONE AUGMENTATION WAS GONE. THE DEFECT WAS NOTICED TO BE LARGER THAN THE ORIGINAL DEFECT. REOPERATION WAS REQUIRED. THE ROOT CAUSE OF THE COMPLICATION IS NOT FULLY UNDERSTOOD. HOWEVER, CONSIDERING THAT THE COMPLICATION OCCURRED WHEN THE MEMBRANE DEGRADES (I.E., APPROXIMATELY 6 MONTHS POSTOPERATIVELY), THE COMPLICATION MAY HAVE BEEN RELATED TO A DEGRADATION RELATED TISSUE REACTION (WELL KNOWN SIDE EFFECT OF BIODEGRADABLE IMPLANTS) ALTHOUGH THIS TYPE OF REACTIONS USUALLY DO NOT CAUSE BONE LOSS, ONLY A LOCAL FLUID ACCUMULATION/SWELLING. IT SHOULD BE NOTED THAT THE OBSERVED REACTION MAY ALSO HAVE BEEN CAUSED BY THE USED BOVINE ORIGIN XENOGRAFT BONE VOID FILLER MATERIAL (GEISTLICH BIOOSS). AS STATED IN THE PRODUCT-SPECIFIC INSTRUCTIONS FOR USE OF THE INION GTR MEMBRANE: POSSIBLE COMPLICATIONS WITH ANY PERIODONTAL SURGERY INCLUDE THERMAL SENSITIVITY, GINGIVAL RECESSION, FLAP SLOUGHING, RESORPTION OR ANKYLOSIS OF THE TREATED ROOT, SOME LOSS OF CRESTAL BONE HEIGHT, PERFORATION OR ABSCESS FORMATION, INFECTION, PAIN, SWELLING, INFLAMMATION, GINGIVAL IRREGULARITIES, AND COMPLICATIONS ASSOCIATED WITH THE USE OF ANAESTHESIA. IMPLANTATION OF FOREIGN MATERIALS CAN RESULT IN AN INFLAMMATORY RESPONSE OR ALLERGIC REACTION. TRANSIENT LOCAL FLUID ACCUMULATION MAY OCCUR IN STERILE CIRCUMSTANCES.