This pi is for patient 8 of 10.Surgeon reported he is experiencing a high complication rate with patients whose primary procedures were mako procedures.The nature of the 10 cases is unknown at the time of report.Complications reported include effusions, pain, stiffness, possibly requiring 'scopes' and/ or poly exchanges.The nature of intervention for each of the 10 patients is unknown.
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This pi is for patient 8 of 10.Surgeon reported he is experiencing a high complication rate with patients whose primary procedures were mako procedures.The nature of the 10 cases is unknown at the time of report.Complications reported include effusions, pain, stiffness, possibly requiring 'scopes' and/ or poly exchanges.The nature of intervention for each of the 10 patients is unknown.
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Reported event: it was reported, " this pi is for patient 8 of 10.Surgeon reported he is experiencing a high complication rate with patients whose primary procedures were mako procedures.The nature of the 10 cases is unknown at the time of report.Complications reported include effusions, pain, stiffness, possibly requiring 'scopes' and/ or poly exchanges.The nature of intervention for each of the 10 patients is unknown.¿ product evaluation and results: review of the case session files was not performed as case session data was not provided.Product history review product history review was not performed as the robot and catalogue number was not provided.Complaint history review complaint history review was not performed as the robot and catalogue number was not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data, robot information, catalog number, imaging studies, operative reports, laboratory reports and pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.
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