Description of Event or Problem · 1
IN (B)(6) 2009, PATIENT UNDERWENT ANTERIOR CERVICAL CORPECTOMY USING MODULAR VERTE-STACK ANATOMIC PEEK SYSTEM CLEARED UNDER PREMARKET NOTIFICATION APPLICATION [(B)(4)] IN FOOTPRINT OF 11MM X 14MM, CONSISTING OF TWO END CAPS IN HEIGHT OF 8MM WITH PART NUMBERS 6240841, AND A SINGLE 5MM CENTER STRUT WITH PART NUMBER 6241041. ASSEMBLED THE CERVICAL CORPECTOMY CAGE CONSTRUCT HAD A HEIGHT OF 21MM AND FOOTPRINT OF 11MM X 14MM-- A CONSTRUCT SIZE AND CAGE GEOMETRY THAT CAN ONLY FIT INTO THE ANTERIOR CERVICAL SPINE. THE VERTE-STACK MODIFICATION, HOWEVER, WAS CLEARED AS A CORPECTOMY CAGE INTENDED FOR USE BELOW THE NECK IN THE KYPHOTIC THORACIC SPINE AND MUCH LARGER LORDOTIC SPINE. THE LABELING OR THE VERTE-STACK CONTRAINDICATES USE IN THE CERVICAL SPINE, YET THE DEVICE DESIGN AND CAGE GEOMETRIES ONLY PERMIT USE AND IMPLANTATION INTO THE ANTERIOR CERVICAL SPINE. THE VERTE-STACK ANATOMIC PEEK END CAPS IN 11MM X 14MM FOOTPRINTS ARE IDENTICAL TO THE STAND ALONE ANATOMIC PEEK CERVICAL INTERBODY SPINAL CAGES CLEARED UNDER (B)(4). THE ANATOMIC PEEK IS INTENDED FOR AN BY CONSTRUCT CAN ONLY BE USED FOR SINGLE-LEVEL ANTERIOR CERVICAL INTERBODY FUSION. THEREFORE TWO VERTE-STACK ANATOMIC PEEK END CAPS IN IDENTICAL FOOTPRINTS WOULD STAND TO REASON WOULD BE TO REPLACE MORE THAN ONE-LEVEL INTERBODY DISC SPACE, AND ADDING A STRUT WHICH WOULD INCREASE THE CONSTRUCT HEIGHT MORE WOULD FORM A CONSTRUCT INTENDED FOR VERTEBRAL BODY REPLACEMENT. NEITHER THE VERTE-STACK ANATOMIC PEEK OR ANATOMIC PEEK DEVICES WERE APPROVED OR CLEARED FOR CERVICAL VERTEBRAL BODY REPLACEMENT AND REQUIRE SUCH AN INTENDED USE IN THE DEVICE CONSTRUCT TO BE SUBMITTED UNDER A DE NOVO AS FDA HAS NOT APPROVED A THERMOPLASTIC, MODULAR STATIC DEVICE FOR CERVICAL CORPECTOMY. THE PATIENT DEVELOPED POST OPERATIVE COMPLICATIONS, INCLUDING, BUT NOT LIMITED TO BILATERAL PAIN, WEAKNESS, NUMBNESS, AND PARESIS TO THE UPPER EXTREMITIES, DYSPHONIA, DYSPHAGIA, INCONTINENCE AND PROBLEMS WITH GAIT. REVISION SURGERY WAS PERFORMED ABOUT THREE YEARS LATER.