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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Physical Asymmetry (4573)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).This report is for an unk - constructs: pfna-ii/unknown lot.Part and lot numbers are unknown; udi 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 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, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: nie, s.B.Et al.(2020), medial support nail and proximal femoral nail antirotation in the treatment of reverse obliquity inter-trochanteric fractures (arbeit gemeinschaft fur osteosynthesfrogen/orthopedic trauma association 31-a3.1): a finite-element analysis, chinese medical journal, vol.133(22), pages 2682-2687 (china).This study presents a case report of a (b)(6)-year-old female patient who had reverse obliquity inter trochanteric fractures were treated with a novel nail (medial support nail [msn-ii]) and proximal femoral nail anti-rotation (pfna-ii).The femoral stress, implant stress and fracture site displacement of msn-ii was less than that of pfna-ii.As the loading stress increased, the displacement of the fracture site gradually increased.The displacement in the pfna-ii model was larger than that in the msn-ii model this report is for an unknown synthes pfna-ii.This report is for (1) unk - constructs: pfna-ii.This report is 1 of 1 for (b)(4).
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Search Alerts/Recalls
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