Perforator was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.The unit was heavily soiled with organic material, it had bone fragments lodged between the inner and outer drill.The label was destroyed.Ifu testing was performed with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.Root cause - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.Additional information received: when the patient was discharged on september 5, the doctor reported the following comments: "neurologically we find a coherent and oriented patient, presenting no language disorder.The patient evokes an altered spatial perception, great fatigue, but also concentration disorders.This hemineglect and left hemiparesis persists with a defect grip, but in good recovery thanks to physiotherapy.The patient also mentions coordination problems when carrying out certain tasks.He has no headaches, nor any other sign of intracranial hypertension.There is no comitial crisis." "this patient did not have consultation at our center since.".
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