Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed and no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch,.
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2021.The patient underwent the revision surgery due to the infection removing the tfna implants and injecting the cement.The surgeon thought there was no problem with the implants and osteomyelitis might be the cause.On (b)(6), 2021, the patient underwent the implant surgery for the femur with the tfna implants.The surgery was completed successfully without any surgical delay.The patient outcome was stable.No further information is available.This complaint involves five (5) devices.This report is for (1) ti end cap for tfna 0mm extn - sterile this report is 3 of 5 (b)(4).
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