Device used for treatment, not for diagnosis.Richamond, j; etal (2004), nonunions of the distal tibia treated by reamed intramedullary nailing, j orthop trauma 18: 603-610.(b)(4): the investigation could not be completed; 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.(b)(4).
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This report is being filed after subsequent review of the following literature article: richamond, j; etal (2004), nonunions of the distal tibia treated by reamed intramedullary nailing, j orthop trauma 18: 603-610.The purpose of this study is to determine the efficacy of reamed intramedullary nailing in the treatment of nonunions of the distal one-fourth of the tibia.Nonunions of the distal tibia are particularly difficult to treat given the short distal segment, the proximity to the ankle joint, and the fragile soft-tissue envelope.Intramedullary nailing is an attractive solution to this problem because it avoids extensive dissection, and the implant remains intraosseous, posing minimal problem for the soft tissues.Thirty-two patients (23 males and 9 females, average age of 43 years) with nonunions of the distal one fourth of the tibia who were treated by reamed, locked intramedullary nailing over a 10-year period (1992-2002) at a single institution were identified in a fracture database.Data was collected by retrospective chart and radiograph review.All necessary instrumentation was removed first.Next, schanz pins for the large femoral distractor (synthes, (b)(4)) were placed under fluoroscopy parallel to the knee and ankle joints, as far proximally and distally as possible, with the distractor placed on the concave side if coronal plane deformity was present.Average length of follow-up was 25 months (range 4 - 81 months).Twenty-nine out of 32 patients achieved union at an average of 3.5 months after reamed, locked intramedullary nailing.Of the remaining three, 2 patients united after dynamization (one at 4 months after dynamization and the other at 7 months), and the third patient united 4 months after exchange nailing.Deformity was corrected to a maximum of 4 degree in all planes.Seven patients had a history of infection, but no patients had signs of active infection at the time of surgery.Four patients had positive intraoperative cultures, and only 2 required removal of the nail after achieving union to control infection.There were no signs of chronic osteomyelitis in these 2 patients at the date of the last follow-up visit; 5.5 years and 2 years following nail removal.Reamed, locked intramedullary nailing is a reliable and safe procedure in the treatment of nonunions in the distal one fourth of the tibia, even in the setting of prior infection or external fixation.It allows for excellent correction of deformity, which is an essential component of the procedure.A copy of this article will be attached to the medwatch.This is report 3 of 4 for (b)(4).This report is for an unknown reamed intramedullary nailing and refers to the serious injury for two unknown patients who experienced removal of nail after union due to staphyloccocus aureus infection.
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