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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Arthritis (1723)
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Event Date 05/14/2013 |
Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown - plates: foot/unknown ot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary 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, 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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Device report from synthes reports an event in india as follows: this report is being filed after the review of the following journal article: singh, a.K.And vinay, k.(2013), surgical treatment of displaced intra-articular calcaneal fractures: is bone grafting necessary?, journal of orthopaedics and traumatology, vol.14 (issue 4), pages 229-305 (india).The aim of this study is to compare the outcomes and complications of two methods utilized for the surgical treatment of intra-articular calcaneal fractures.Between december 2002 to december 2010, a total of 390 patients underwent open reduction and internal fixation of the calcaneus.These patients were divided into 2 groups: group a (n=200; 152 male and 50 female) with an average age of 40 (range 18-74) years were treated with bone grafting and group b (n=188; 130 male and 58 female) with an average age of 41.2 (range 18-75) years were treated without bone graft.Surgery was performed using unknown synthes locking plates and screws.The average overall duration of follow-up was 2 years.The following complications were reported as follows: 50 patients had subtalar arthrosis.27 patients were in group a and 23 patients were in group b.26 patients had superficial wound dehiscence.25 patients had wound infection.Of the 390 patients, 13 had subtalar fusion; 7 of which were in group a and 6 were in group b.According to aofas ankle-hindfoot scores, group a had 50 patients with fair results and 8 patients with poor results.While group b had 36 patients with fair results and 7 patients with poor results.This report is for an unknown synthes plates and unknown synthes locking screws.This report is for one (1) unk - plates: foot.This complaint involves two (2) devices.This report is for 1 of 2 for (b)(4).
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Search Alerts/Recalls
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