Description of Event or Problem · 1
A SURGEON REPORTED THAT A (B)(6) MALE WHO RECEIVED 2 UNITS OF OP-1 IMPLANT, 15 CC'S OF CALSTRUX BONE MARROW ASPIRATE AND CANCELLOUS CHIPS AS PART OF A LUMBAR SPINAL FUSION IN (B)(6) 2006, EXPERIENCED A PERSISTENT LOW-GRADE FEVER AND A LARGE SEROMA IN THE SURGICAL BED AS EVIDENCED BY MRI APPROXIMATELY 2 WEEKS FOLLOWING SURGERY. ALL CULTURES WERE NEGATIVE AND THE PATIENT HAD A NORMAL SEDIMENTATION RATE, WHITE BLOOD CELL COUNT, C-REACTIVE PROTEIN AND CHEST X-RAY. THE PATIENT WAS PLACED ON PROPHYLACTIC ANTIBIOTICS AND HAS BEEN TAKING THEM FOR APPROXIMATELY 10 WEEKS. ON (B)(6) 2006, THE PATIENT BEGAN COMPLAINING OF WORSENED BACK PAIN AND A RECURRENCE OF THE FEVER. LAB RESULTS INCLUDED A WHITE BLOOD CELL COUNT OF 17 (NORMAL RANGE UNKNOWN), A SEDIMENTATION RATE OF 4 (NORMAL RANGE UNKNOWN), AND A C-REACTIVE PROTEIN OF 1.7 (NORMAL RANGE UNKNOWN). TESTING ALSO INCLUDED A CHEST X-RAY AND URINALYSIS WHICH WERE BOTH NORMAL, AND AN MRI (DONE ON (B)(6) 2006) WHICH NOTED THAT THE PREVIOUSLY OBSERVED LARGE FLUID COLLECTION HAD RESOLVED, BUT THAT THERE HAD BEEN INTERVAL DEVELOPMENT OF MARKED EDEMA THROUGHOUT THE PARASPINAL MUSCLES POSTERIOR TO THE L4-5 AND L5-S1 LEVELS. THE SURGEON WAS CONCERNED BECAUSE OF THE SEVERITY OF THE PARASPINAL SWELLING. HE SAID IT WAS FAR MORE SEVERE THAN ANYTHING HE HAS EVER SEEN. THE PATIENT WAS STARTED ON MOTRIN AND THE SURGEON PLANNED TO DISCONTINUE THE CURRENT ANTIBIOTICS AND OBSERVE FOR TEMPERATURE SPIKES OR OTHER LAB CHANGES. THE SURGEON SUSPECTS THE EVENTS ARE RELATED TO OP-1 IMPLANT. ADDITIONAL INFORMATION IS EXPECTED. DESPITE THE CURRENT NONSERIOUS STATUS OF THIS CASE, IT WAS DECIDED TO SUBMIT IT IN AN EXPEDITED MANNER.