Description of Event or Problem · 1
ON (B)(6)2007, THE PT UNDERWENT PLACEMENT OF THE AXIALIF -TRANS1- DEVICE -TRANS1, INC., (B)(4)- FOR SPONDYLOLISTHESIS AT L5-S1 THROUGH A PARACOCCYGEAL APPROACH COMBINED WITH MINIMALLY INVASIVE PEDICLE SCREW FIXATION AT L5-S1. THE PT DEVELOPED SEVERE POST-OPERATIVE COMPLICATIONS INCLUDING ANTERIOR AND POSTERIOR INFECTIONS REQUIRING FOUR ADDITIONAL PROCEDURES OVER THE NEXT NINE MONTHS INCLUDING REMOVAL OF THE AXIALIF DEVICE AND POSTERIOR SCREWS AND RODS. DESPITE TREATMENT WITH ANTIBIOTICS AND REMOVAL OF THE AXIALIF DEVICE, THE PT DEVELOPED PROGRESSIVE INFECTION WITH SPREAD OF OSTEOMYELITIS TO THE L4-L4 AND L2-L3 DISCS AS WELL AS DESTRUCTION OF THE L4 VERTEBRA. THE PT DEVELOPED A NEW SPONDYLOLISTHESIS AT L4-L5. THE PT PRESENTED TO OUR PRACTICE AND REQUIRED TWO EXTREMELY COMPLEX SURGICAL PROCEDURES TO TREAT ONGOING INFECTION -FIRST PROCEDURE ON (B)(6)2009-. DESPITE APPROPRIATE TREATMENT, THE PT EXPERIENCED ADDITIONAL COMPLICATIONS REQUIRING EXTENSIVE HOSPITALIZATION AND ADDITIONAL PROCEDURES BUT EVENTUALLY RESOLVED THE INFECTION AND HEALED THE NEW FUSION WHICH WAS PERFORMED FROM L2 TO SACRUM. DUE TO THE UNCONVENTIONAL SURGICAL APPROACH REQUIRED FOR THE INITIAL PLACEMENT OF THE AXIALIF DEVICE, IT IS MY OPINION THAT THE DEVICE POSES A RISK OF SERIOUS COMPLICATIONS WHICH ARE NOT COMPARABLE TO A STANDARD ANTERIOR LUMBAR INTERBODY FUSION USING MORE TRADITIONAL APPROACHES AND USE OF THIS DEVICE SHOULD BE RESTRICTED.