INFUSE BONE GRAFT LARGE KIT

Additional Manufacturer Narrative

(B)(4). LITERATURE CITATION: GLIED, ET AL). OFF-LABEL USE OF RHMBP-2 FOR RECONSTRUCTION OF CRITICAL-SIZED MANDIBULAR DEFECTS: THREE CASE REPORTS. 2010 JUNE/JULY. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. WITHOUT RETURN OF THE DEVICE OR ASSOCIATED RECORDS IT IS NOT POSSIBLE TO ASCERTAIN A CAUSE FOR THE REPORTED EVENT. (B)(4): PSEUDARTHROSIS.

Description of Event or Problem

IT WAS REPORTED THAT RHBMP-2 WAS USED IN THIS PATIENT WHO WAS DIAGNOSED WITH A FRACTURED MANDIBULAR RECONSTRUCTION PLATE THREE YEARS AFTER A MANDIBULAR RESECTION FOR OSTEOMYELITIS. A TRANS-CERVICAL APPROACH WAS USED TO CREATE A POCKET OF TISSUE SURROUNDING A RECONSTRUCTION PLATE WHEREIN A CADAVERIC RIB, PREVIOUSLY SOAKED IN SALINE, WAS ADAPTED SUPERIOR TO THE PLATE AND SECURED WITH 12MM BONE SCREWS ON EITHER SIDE OF THE DEFECT. TWENTY-FOUR MG RHBMP-2/ACS WAS PLACED PASSIVELY INTO THE POCKET, FOLLOWED BY A STANDARD LAYERED CLOSURE. THE SURGERY WAS UNEVENTFUL. THREE DAYS INTO RECOVERY, THE PATIENT COMPLAINED OF INCREASING PAIN AND A FEELING THAT SHE WAS LOSING HER VOICE. EXAMINATION, INCLUDING FIBEROPTIC LARYNGOSCOPY, REVEALED NO VOCAL CORD OR LARYNGEAL EDEMA OR ABNORMALITIES; THE PROBLEM RESOLVED SPONTANEOUSLY IN THE FOLLOWING TWO DAYS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL SEVEN DAYS AFTER SURGERY. SHE WAS SEEN IN THE FOLLOWING WEEKS; THE SOFT TISSUES WERE HEALING WELL. AT 8 AND 12 MONTHS FOLLOWING SURGERY, PANORAMIC RADIOGRAPH REVEALED LITTLE BONE FORMATION IN THE DEFECT, WITH SOME CALCIFICATIONS SUPERIORLY. THE PATIENT ELECTED TO UNDERGO CONVENTIONAL RECONSTRUCTION, BUT HAS YET TO DO SO. AMONG THE POSSIBLE FACTORS THAT MAY HAVE LEAD TO INSUFFICIENT BONE FORMATION, THE AUTHORS SUGGEST: THE ABSORBABLE COLLAGEN SPONGE (ASC) WAS PLACED IN A PERIOSTEAL POCKET AND "TENTED" WITH CADAVERIC RIB - SINCE THE ACS LACKS ANY STRUCTURAL STABILITY, IT MAY HAVE COLLAPSED AROUND THE RIB, OR THE CADAVERIC RIB MAY HAVE PROVIDED AN INSUFFICIENT FRAMEWORK NECESSARY FOR ADEQUATE BONE FORMATION.