(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure, date and name of initial index procedure, were there any intra-operative complications? other relevant patient history/concomitant medications , product code and lot #, what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? what medical intervention was given for the pain management? results? if reoperation was performed please provide date and surgical findings.Was the device removed? if so, please date and details of the re-operation.
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