On october 14, 2020 it was reported that the accushape peek patient-specific cranial implant was explanted.A surgical nurse who was present at the time of the reported event was contacted by telephone on november 04, 2020.According to this communication, the device in question was reportedly explanted on (b)(6) 2020 after the patient experienced an epidural hematoma.The patient reportedly had "a lot of issues" including a "severely damaged brain" from preexisting health conditions.According to the nurse, the patient had undergone a previous decompressive craniectomy, tracheostomy, and had also previously experienced a ruptured brain aneurism before the device in question was implanted.In the nurse's opinion, the epidural hematoma experienced by the patient was "definitely not from the implant." analysis of production records for the device in question found that the materials and processes used to produce the device in question were in conformance with production requirements.Records contained within the device history record showed that the device in question satisfied all required in-process inspection criteria.Investigation did not identify any device problems.Production records showed that medcad provided a replacement peek patient-specific implant for the patient on (b)(6) 2020.According to communication with the surgical nurse, the replacement cranial implant was implanted on (b)(6) 2020 without incident.The cause of the reported epidural hematoma could not be established.
|