This report is for an unknown maxframe/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number 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.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 underwent a deformity correction in children for the correction of bony or soft tissue deformities in tibia/fibula area.There was a union of fracture in about 11 weeks duration.Postoperatively, the patient experienced a peroneal nerve neuropathy.No difficulties and patient harm reported using 3d maxframe software.Patient outcome is that the neuropathy was resolved.No further information is available.This report is for an unknown maxframe.This is report 1 of 2 for complaint (b)(4).
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