Description of Event or Problem · 1
ON (B)(6) 2010, STRYKER BIOTECH REVIEWED AN ARTICLE FROM THE LITERATURE: A PROSPECTIVE, RANDOMIZED, CONTROLLED, MULTICENTER STUDY OF OSTEOGENIC PROTEIN-1 IN INSTRUMENTED POSTEROLATERAL FUSIONS BY DELAWI ET AL, SPINE, 2010, VOL 12, 1185-1191. THE LITERATURE ARTICLE MENTIONED ADVERSE EVENTS IN PT WHO RECEIVED OSIGRAFT IN CONJUNCTION WITH PEDICLE SCREW INSTRUMENTATION AND AUTOGRAFT AS PART OF STUDY TO TREAT DEGENERATIVE AND ISTHMIC SPONDYLOLISTHESIS. IT IS HIGHLY LIKELY THAT SEVERAL OF THE ADVERSE EVENTS DESCRIBED IN THE PAPER HAVE BEEN REPORTED PREVIOUSLY TO STRYKER BIOTECH. THE ARTICLE STATES THAT 10 OF 18 PTS IN THE OP-1 GROUP EXPERIENCED AN ADVERSE EVENT IN THE FOLLOWING AREAS: RESPIRATORY (N=1), CARDIOVASCULAR (N=1), DURAL TEAR (N=1), SURGICAL INFECTION (N=1), MALIGNANCY (N=1), HEMATOMA (N=2), NEURAL INJURY (N=1), HERNIATION (N=1), EXCESSIVE LEG PAIN (N=1). THIS COMPLAINT IS BEING SUBMITTED AS AN AGGREGATE REPORT UNTIL FURTHER INFO IS RECEIVED.