The following products were used in the surgery: product id: cx01b, lot: unknown, 510(k): k163032, udi: (b)(4), qty: 2, product code: ndn, implant date: (b)(6) 2019.Product id: kpx153rb, lot: unknown, 510(k): k101864, udi: (b)(4), qty: 1, product code: hrx, not implantable.Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient underwent a complex spine procedure with estimated time of 13 hours consisting hardware removal surgery, posterior spine fusion and 2-level kyphoplasty at t9-t10.After the procedure, the patient was flipped and extubated.The patient did not wake up; and expired.The reason for patient death is reported to be unknown.
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