This report is for an unknown plate / unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review / investigation.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.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: kitaura, y.Et al (2019), spontaneous osteonecrosis of the tarsal navicular: a report of two cases, case reports in orthopedics, vol.2019, article id 5952435, pages 1-8 (japan).This study presents a case report of 2 cases of spontaneous osteonecrosis of the tarsal navicular who had a slightly collapsed tarsal navicular and arthritic changes in the talonavicular and medial naviculocuneiform joints.A case report of a (b)(6) year-old female patient presented with a 10-month history of left midfoot pain without any trauma.She was diagnosed as having osteonecrosis of the tarsal navicular based on the findings of plain radiographs from the previous hospital.She was initially treated with an insole.However, the conservative treatment was ineffective for her symptoms.Therefore, arthrodesis was performed using a locking compression plate (lcp) distal radius plate (synthes) and six 2.4 mm locking screws.A radiograph taken 1 year after surgery showed union of the naviculocuneiform joint, but she did not have satisfactory union of the talonavicular joint.The patient had referred pain with the backing out of the most proximal screw which was therefore removed.At 5 years after surgery, a radiograph showed nonunion with mild osteoarthrosis of the talonavicular joint.However, she just had tenderness of the talonavicular joint and had no pain in her usual daily life.The final follow-up jssf midfoot scale score was 97 points.This report is for an unknown synthes plates and unknown synthes screws.This is report 1 of 3 for (b)(4).
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