OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE; ROD, FIXATION, INTRAMEDULLARY
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Device Problem
Migration (4003)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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Between march 2008 and april 2015, a total of 33 patients (19 males and 14 females) with a mean age of 54.64±18.94 were treated with a pfna device (synthes, oberdorf, switzerland).This report is for an unknown pfna blade/unknown lot.Part and lot number 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.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.(b)(4).
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Event Description
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This report is being filed after the review of the following journal article: imerci, a., aydogan, n., and yosun, k.(2018), a comparison of the intertan nail and proximal femoral fail antirotation in the treatment of reverse intertrochanteric femoral fractures, acta orthopaedica belgica, vol.84, pages 123-131 (turkey).The aim of this study was to compare the clinical and radiological results of intertan nail and proximal femoral nail antirotation (pfna) in the treatment of reverse intertrochanteric fractures where the lateral cortex was fractured.Between march 2008 and april 2015, a total of 33 patients (19 males and 14 females) with a mean age of 54.64±18.94 were treated with a pfna device (synthes, oberdorf, switzerland).The minimum follow-up was 1 year.The following complications were reported as follows: patients needed a second surgery because of mechanical failure: 2 patients had a severe blade lateral migration which needed a revision surgery.This report is for an unknown pfna blade.This is report 8 of 9 for (b)(4).
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