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Device Problem
Break (1069)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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510k: this report is for an unknown bone staple/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).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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This report is being filed after the review of the following journal article: mereau, t.M.And ford, t.C.(2006), nitinol compression staples for bone fixation in foot surgery, journal of the american podiatric medical association, vol.96 (2), pages 102-106 (usa).The aim of this retrospective study is to review the use of niti compression staples to detemline whether they are comparable to other methods of fixation.A total of 27 patients (31 feet) underwent arthrodesis or an osteotomy fixated using compression staples.Osstaples (bme, san antonio, texas) were used in 18 feet and a competitor device was used in 13 feet.Minimun follow-up was 3 months.The mean follow-up period was unknown.The following complications were reported as follows: 1 patient showed an asymptomatic broken 25 x 22-mm osstaple at the talonavicular joint at 5 months after surgery (fig.4).In 2 cases, the lateral cortex fractured 6 and 10 weeks after surgery.Both patients remained free of pain, and the fixation appeared to be radiographically stable and healed at 9 and 14 weeks.This report is for an unknown synthes bone staples.This is report 1 of 2 for (b)(4).
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Search Alerts/Recalls
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