There are multiple patients.All known information is provided in the journal article.510k: this report is for an unknown lcp clavicular hook plate/unknown lot.Part and lot number are unknown; udi number is unknown.There are multiple unknown dates of implantation between january 2008 and april 2009.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.(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.(b)(4).
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This report is being filed after the review of the following journal article: lee kw et al (2010)."arthroscopic-assisted locking compression plate clavicular hook fixation for unstable fractures of the lateral end of the clavicle: a prospective study." international orthopaedics.Volume 34.Page 839-845 (south korea).The aim of this prospective study was to assess the clinical outcomes of an unstable fracture of the lateral end of the clavicle treated with an arthroscopic-assisted locking compressive plate (lcp) clavicular hook plate.Between january 2008 and april 2009, a total of 23 consecutive patients with unstable fractures of the lateral end of the clavicle, who were treated surgically, were included in the study.There were 19 men and 4 women with a mean age of 43 years (range, 21-74 years).All patients were treated with an unknown synthes clavicular hook plate.The functional outcomes were assessed using the shoulder scoring system described by constant and murley.Both the subjective and objective clinical data were included, with a maximum score of 100 points.Pain (15 points), the activities of daily living (20 points), the range of shoulder motion (40 points), and muscle power (25 points) were evaluated.After osteosynthesis, plain radiographs (anteroposterior and axial radiographs) were taken once every four weeks for all patients.The mean follow-up period was 13 months (range, 6¿21 months).Complications were reported as follows: 4 patients had some degree of acromial osteolysis.However, these were not symptomatic clinically.3 patients had radiological signs of arthrosis of the acromioclavicular joint with only 1 of these patients experienced clinical symptoms of arthrosis.5 patients had bursitis based on dynamic ultrasonography.3 of these had concurrent of acromial osteolysis due to hook migration and bursitis.A (b)(6) man had a cut-out of the screws and a second fracture (stress) between 2 medial screws at 7 weeks postoperatively.The shoulder was immobilized in a broad arm sling until both fractures healed.The plate was removed three months later.A (b)(6) woman had achieved a full range of shoulder motion, but she complained of mild shoulder discomfort.The arthroscopic view shows subacromial bursitis.The plate was removed and a combined arthroscopic debridement and partial bursectomy were performed.This report is for unknown synthes lcp clavicular hook plates.This is report 3 of 4 for (b)(4).
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