Product complaint #: (b)(4).Additional product code: kwp;kwq;mnh;mni;osh.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.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and/or 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, a follow-up medwatch will be filed as appropriate.
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient had suffered from the adjacent disease.On (b)(6) 2021 a revision surgery was performed without further issue.The primary procedure was performed in 2008 and expedium di was applied.This complaint involves twenty (20) devices.This report involves one (1) rod, 120mm.This is report 20 of 20 for (b)(4).
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