INFUSE BONE GRAFT

Description of Event or Problem

IT WAS REPORTED THAT THE PT HAD LESS THAN 4MM OF RESIDUAL CRESTAL BONE REQUIRING BILATERAL SINUS AUGMENTATION. THE LATERAL SINUS WALL WAS EXPOSED, A COMPLETE OSTEOTOMY WAS MADE AND THE LATERAL WINDOW BONE WAS DISCARDED. INITIAL SINUS MEMBRANE RELEASE WAS ACCOMPLISHED AND EXTENDED UP THE MEDIAL WALL OF THE SINUS - NO PERFORATIONS WERE OBSERVED. PREPARATION OF RHBMP-2/ACS WAS DONE PER MFR'S INSTRUCTIONS. THE SINUSES WERE GRAFTED WITH INFUSE GRAFT AT A CONCENTRATION OF 1.5 MG/ML/ACS COMBINED A MINERALIZED ALLOGRAFT. THE COLLAGEN SPONGES WERE COMPRESSED AFTER A 15-MINUTE BINDING PERIOD TO REMOVE ANY EXCESS WATER. HALF OF THE PARTICLES WERE 0.5 TO 1 MM AND HALF WERE 1 TO 2 MM. ON THE LEFT SIDE, TWO SPONGES WERE CUT INTO STRIPS AND MIXED WITH THE ALLOGRAFT AS A COMPOSITE GRAFT, WHILE FOUR SPONGS WERE USED ON THE RIGHT. THE TOTAL VOLUME OF RHBMP-2 ON THE RIGHT WAS TWICE THAT USED ON THE LEFT. BARRIER MEMBRANES WERE NOT USED OVER THE LATERAL WINDOW. EXTENSIVE POSTOPERATIVE INFLAMMATORY RESPONSE WAS OBSERVED, WHICH HAD RESOLVED BY THE 6-MONTH EVALUATION.

Additional Manufacturer Narrative

(B)(4). LITERATURE CITATION: TAMROW, ET AL. MAXILLARY SINUS AUGMENTATION USING RECOMBINANT BONE MORPHOGENETIC PROTEIN-2/ACELLULAR COLLAGEN SPONGE IN COMBINATION WITH A MINERALIZED BONE REPLACEMENT GRAFT: A REPORT OF THREE CASES. INT J PERIODONTICS RESTORATIVE DENT 2010;30:139-149. A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. NEITHER THE DEVICE NOR (TEST RESULTS OR IMAGING FILMS) WERE RETURNED TO THE MFR FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.