This report is for an unknown plate-construct/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.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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This report is being filed after the review of the following journal article: tiren d., vos d., (2014) correction osteotomy of distal radius malunion stabilised with dorsal locking plates without grafting,strategies trauma limb reconstruction volume 9, pages 53¿58 (netherlands).This study aims to describe the results of distal radius correction osteotomy in patients with symptomatic malunion with dorsal bicolumnar locked plating, without filling the osteotomy defect.Between 2009 and 2011, a total of 11 patients with a symptomatic dorsal malunion of the distal radius were treated.All patients had undergone an opening-wedge osteotomy through a dorsal approach and dorsal bicolumnar locked plating with 2.4 mm columnar stabilisation plates from synthes.At 2, 6 and 12 weeks and if necessary every 6 weeks after 3 months, patients visited the outpatient clinic where the range of movement of the wrist was assessed and x-rays obtained.The following complications were reported as follows: a case of a (b)(6) year old female treated initially with mini ao double plates for the distal radius had pain in rest and movement.The patient underwent opening-wedge osteotomy through a dorsal approach and dorsal bicolumnar locked plating with 2.4 mm columnar stabilisation plates from synthes.A case of (b)(6) year old female had requested removal of the osteosynthesis at 6 months because of a palpable plate below the scar and a wish for correction of the scar.One of the patients had some discomfort with forceful forearm rotation during the final visit which did not limit his daily activities.This report is for an unknown synthes mini ao double plates.This is report 1 of 3 for (b)(4).
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