No allegation of product malfunction.No product will be returned for investigation.Labeling review potential adverse events and complications ".As with any major surgical procedures, there are risks involved in orthopedic surgery.Rarely, some complications may be fatal.".
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On (b)(6) 2017, a patient underwent posterior percutaneous spinal fixation at the t9-s2 levels.At the time of closing the surgical incisions, patient's oxygen saturation level dropped and the patient went into cardiac arrest state.Patient was treated by an anesthesiologist but did not recover.No allegation of product malfunction.
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