ORTHOBLAST

Description of Event or Problem

(B)(6) 2003, SURGEON IMPLANTED UNAPPROVED BIOLOGIC ORTHOBLAST 11 IN COMBINATION WITH HEALOS, INVERTEBRAL AR SPACER AND BIOMET EBI IMPLANTABLE BONE STIMULATOR. THE ORTHOBLAST DEVICE DID NOT HAVE FDA CLEARANCE AT TIME OF PROCEDURE [510 (K) K050642 ((B)(6) 2005)]; SURGEON (S) CONDUCTED UNAUTHORIZED CLINICAL TRIALS USING ABOVE COMBINATION OF DEVICES WITHOUT OBTAINING IDE, IRB OR CONSENT FROM PT. PT DEVELOPED SEVERE POST-OPERATIVE COMPLICATIONS, INCLUDING BUT NOT LIMITED TO, ADVERSE SWELLING, INFECTION, RADICULOPATHY AND MYELOPATHY NECESSITATING IMPLANTATION OF A TENS PAIN UNIT, ESOPHAGEAL REMEDIAL SURGERY, AND INTRATHECAL PAIN PUMP.