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Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Non-union Bone Fracture (2369); Impaired Healing (2378)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Metzl, j.Et al (2013) a clinical and radiographic comparison of two hardware systems used to treat jones fracture of the fifth metatarsal.Foot and ankle international 34(7): 956-61.This report is for unknown screw, unknown quantity, unknown lot.Other number: udi- unknown part number, udi is unavailable (b)(4).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.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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Literature article received: this report is being filed after the subsequent review of the following literature article, metzl, j.Et al (2013) a clinical and radiographic comparison of two hardware systems used to treat jones fracture of the fifth metatarsal.Foot and ankle international 34(7): 956-61.Forty-seven patients underwent surgery (47 feet) for a jones fracture between 1999 and 2007, performed by 4 foot and ankle fellowship-trained orthopaedic surgeons at one institution.Twenty-six patients (26 feet) were treated with the indication-specific screw (group i), while 21 patients (21 feet) were operated on with the traditional screw (group ii)--of the traditional screw group, 17 patients were treated with 4.5mm synthes asif malleolar screws and 3 patients treated with 6.5mm synthes asif malleolar screws.The average patient age was 43.8 years of age.One patient in the indication-specific group and 5 patients in the traditional screw group had a preexisting diagnosis of diabetes.Bone graft was added to the fracture in 5 patients in the indication-specific screw group and 4 patients in the traditional screw group.All patients who received bone graft had a delayed union or non union of 3 months or more based on patient history, physical examination and plain radiographs.This is report 1 of 2 for (b)(4).This report is for unknown synthes asif malleolar screw and refers to the following: 2 implant failures (radiographic nonunion both of which went on to hardware failure).
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Search Alerts/Recalls
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