On or about (b)(6) 2016, patient had 360 lumbar fusion surgery from l4 to s1.A genesys screw system was implanted into patient's spine during the fusion surgery.Specifically, it was one genesys pedicle screw (size) 6.5x40, catalog number g741-65-40, lot number wt20151021a), two genesys screws (size 6.5x45, catalog number g741-65-45, lot number wt20151208b), and three genesys set screw caps (catalog number g826, lot number tw20160219).Approximately four months after the fusion surgery, patient was having a rough time with pain in the back, around the area of the incision and felt miserable.After the fusion surgery, it was discovered that the patient's problems were probably secondary to painful genesys hardware.On (b)(6) 2017, patient had lumbar genesys hardware removal surgery.The admitting diagnosis was a "mechanical complication" with patient's genesys hardware.The genesys hardware and screws were visibly defective because the genesys screw system did not have a flat, smooth, and slick surface on the head of each screw.This defect prevented seamless movement of patient's muscle tissue, nerves and skin across the top of each screw after implantation.This defect caused patient to suffer painful internal lacerations of muscle tissues, nerves, and skin with each bodily movement for approximately nine months.
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