Information was received from healthcare professional via manufacturer representative regarding an event that occurred during a surgery as part of a clinical study on a patient with the following medical history and diagnosis: approximate duration of back pain symptoms that resulted in planned surgery: 96 months approximate duration of leg pain symptoms that resulted in planned surgery: 60 months how long has the patient been treated with conservative care? (complete 0 if no care): 96 months -non-smoker -physical therapy or osteopathy -bracing/orthroses -spinal injections/nerve blocks -pain medications -hyperlipidemia -osteoarthritis it was reported that the patient had a bleeding during surgery which required a blood transfusion of 1l.The bone bleeding at the level of the sarcum and afterwards at the level of the lower plateau of l5 was relatively important.Patient had vas score two days after surgery, on (b)(6) 2017 and was discharged on (b)(6) 2017.There is no product allegation regarding the retractor instrument.Product return status is unknown, and its replacement status is unknown.No other patient injury / complication was reported.
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