Description of Event or Problem · 1
PT UNDERWENT SPINAL FUSION SURGERY TO CORRECT A CURVATURE OF THE SPINE. IT WAS DECIDED THAT THE STRYKER OP-1 PUTTY WOULD BE USED ALONG WITH THE PT'S HIP BONE TO PROMOTE BONE GROWTH IN THE SPINE AREA. MULTIPLE TESTS-CT SCAN, ULTRASOUND, MRI, BONE SCAN, BRAIN SCAN, COLONOSCOPY - SHOWED THAT THERE WAS A SMALL TUMOR ON ONE KIDNEY. ALL OTHER TESTS WERE NEGATIVE AND SHOWED NO OTHER INDICATIONS OF CANCER IN OTHER BODY PARTS. A FULL NEPHRECTOMY WAS PERFORMED TO REMOVE THE KIDNEY WITH THE TUMOR. PATHOLOGY SHOWED THAT MARGIN AREAS WERE CLEAN, INDICATING COMPLETE REMOVAL OF CANCER. HOWEVER, THE TUMOR WAS DETERMINED TO HAVE A SARCOMATOID TUMOR, VERY RARE AND VERY AGGRESSIVE TYPE. THREE WEEKS AFTER SURGERY BEGAN TO EXPERIENCE SIMILAR PAIN AGAIN. CT SCAN SHOWED THE CANCER HAD RETURNED AND HAD SPREAD TO LIVER AND LUNGS AS WELL AS BEING AT ORIGINAL SITE. DECISION WAS MADE TO TRY AVASTIN/TARCEVA TREATMENT, AFTER 1 MONTH THE CONDITION WAS WORSE AND THE CANCER CONTINUED TO PROGRESS; 3 WEEKS LATER PT PASSED AWAY. RPTR CONTACTED THE SURGEON TO SEE IF THIS INCIDENT HAD BEEN REPORTED TO STRYKER. HE TOLD RPTR HE WOULD FOLLOW UP. HE RECEIVED A FAX FROM STRYKER BIOTECH PHARMACOVIGILANCE MGR, ASKING FOR MORE INFO. THE REQUESTED INFO WAS RETURNED BUT NO FURTHER RESPONSE WAS RECEIVED. THIS INCIDENT DOES NOT APPEAR TO HAVE BEEN REPORTED TO THE FDA. RPTR WOULD LIKE TO KNOW WHY THIS EVENT WAS NOT REPORTED BY STRYKER WITHIN 10 DAYS AFTER THEY WERE NOTIFIED, AS REQUIRED BY LAW, AND WHAT ACTION WILL BE TAKEN IN THIS CASE. PT TOOK PERCOCET FOR PAIN AFTER THE SURGERY FOR APPROX 2 MONTHS (UNTIL 1/05).