Description of Event or Problem · 1
LIFE SPINE CAGE AND SCREWS DID NOT HAVE SPACE TO ALLOW FOR PROPER FUSION IN LOWER BACK SURGERY (L4-L5). BONE GRAFTING MATERIAL FELL OFF AND LANDED IN THE PT'S SPINAL CANAL ON THE SCIATIC NERVE ROOT. AN EMERGENCY SECOND SURGERY WAS PERFORMED TO REMOVE THE MATERIAL. ALSO AFTER ONE YEAR THE SCREWS ARE COMING LOOSE. ON (B)(6) 2017 (B)(6) HAD SURGERY AT (B)(6), BY DR (B)(6), NEUROSURGEON. WITHIN 24 HOURS FROM SURGERY, WHILE STILL IN HOSP, MRS (B)(6) REPORTED PAIN DOWN HER RIGHT BUTT CHEEK, LOWER BACK, AND DOWN HER LEG. FOR THE NEXT 5 WEEKS MRS (B)(6) WAS BEDRIDDEN AND COULD NOT GET OUT OF BED TO EVEN TALK TO THE BATHROOM. SHE CRIED OUT WITH PAIN AND DR RECOMMENDED TO TAKE MORE PAIN PILLS. AFTER 5 WEEKS, HUSBAND TRANSPORTED MRS (B)(6) TO (B)(6) EMERGENCY ROOM. CT REVEALED THE BONE GRAFTING MATERIAL HAD FALLEN FROM THE LIFE SPINE CAGE AND LANDED IN THE SPINAL CANAL AND ON THE SCIATIC NERVE. AN EMERGENCY SURGERY WAS PERFORMED TO REMOVE THE MATERIAL ON (B)(6) 2017. MRS (B)(6) WAS BETTER AND HEALING, BUT STILL HAVING PAIN IN BACK, RIGHT BUTT CHEEK, AND LEG. ON (B)(6) 2017, AN MRI REVEALED MORE FALLING MATERIAL IN THE SPINAL CANAL. DR TOLD HER TO LIVE WITH IT. ON (B)(6) 2018 SHE SAW A DIFFERENT SURGEON AND A CT SCAN REVEALED THE SCREWS WERE COMING LOOSE. A THIRD MORE INVASIVE SURGERY IS RECOMMENDED TO REMOVE THE IMPLANTED LIFE SPINE CAGE AND SCREWS AND PUT A LARGER CAGE AND SCREWS IN MRS (B)(6) BACK. DR SAID THE LIFE SPINE CAGE IS TOO SMALL. LIFE SPINE, INC., WAS NEGLIGENT IN THE PT'S CARE AND DEPARTED FROM ACCEPTABLE MEDICAL STANDARDS OF PRODUCT SAFETY: USED DEFECTIVE MEDICAL DEVICE PRODUCTS THAT WERE UNABLE TO ALLOW PROPER FUSION; USED FAILED / DEFECTIVE SCREWS AND MATERIAL THAT STRIPPED OUT; FAILED TO FOLLOW UP WITH APPROPRIATE TESTING; FAILED TO NOTIFY THE FDA PROMPTLY ONCE A CLAIM WAS SUBMITTED; THEY WERE UNABLE TO MAINTAIN THE HEALTH AND SAFETY OF PT. LIFE SPINE, INC., FAILED TO PROPERLY TRAIN DR (B)(6) ON THEIR INNOVATIVE PRODUCTS, AS ADVERTISED ON THEIR WEBSITE.