This report is for unknown plate.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.Pma/510(k) number is not available.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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: d.Tiren, a.J.M.Van bemmel, d.J.Swank, f.M.Van der linden (2012)."hook plate fixation of acute displaced lateral clavicle fractures: mid-term results and a brief literature overview." journal of orthopaedic surgery and research.Page 1-8 (the netherlands).The purpose of this study is to evaluate the results and long term effects in use of this plate.From 2001 to 2008, 28 consecutive patients with acute displaced lateral clavicle fractures, treated with the clavicle hook plate were included in this retrospective analysis.Mean age was 38 years (range 15-64), male to female ratio was 21 to 7.Fourteen patients had a right sided and fourteen had a left-sided fracture.All patients had an edinburgh type 3b1/ neer type ii fracture.All patients had suffered a monotrauma.The clavicle hook plate used in this study is a pre-contoured stainless steel, dynamic compression plate with a wider anterolateral end and a lateral extension into a hook which is placed below the acromion.Objective and subjective shoulder function evaluation was performed with the dash and constant-murley scoring systems after which patients were radiographically assessed.After a mean follow up of 6 months (range 2-14 months), the plate was removed under general anesthesia.The following complications were reported as follows: patient 2 - (b)(6) male underwent plate removal due to impingement and subacromial osteolysis was seen in the x-ray.Patient 4 - (b)(6) male had acromioclavicular joint arthrosis seen in the x-ray.Patient 6 - (b)(6) male had plate removal due to impingement and subacromial osteolysis was seen in the x-ray.Patient 7 - (b)(6) female underwent plate removal due to impingement.Patient 8 - (b)(6) female had subacromial osteolysis seen in the x-ray.Patient 10 - (b)(6) male had extra-articular ossification seen in the x-ray.Patient 11 - (b)(6) male underwent plate removal due to pain.This patient was diagnosed with acromioclavicular joint arthrosis and had to undergo lateral clavicle resection.Patient 13 - (b)(6) male underwent plate removal due to impingement.Patient 14 - (b)(6) male underwent plate removal due to impingement and subacromial osteolysis was seen in the x-ray.Patient 18 - (b)(6) male had acromioclavicular joint arthrosis as seen in the x-ray.Patient 19 - (b)(6) male had wound infection; subacromial osteolysis was also seen in the x-ray.Patient 21 - (b)(6) male underwent plate removal due to impingement and acromioclavicular joint arthrosis was seen in the x-ray.Patient 22 - (b)(6) male underwent plate removal due to impingement; poliomyelitis and extra-articular ossification were also seen in the x-ray.Patient 24 - (b)(6) female had nonunion as seen in the x-ray.Patient 25 - (b)(6) female underwent plate removal due to impingement.Patient 26 - (b)(6) male underwent plate removal due to impingement and subacromial osteolysis was seen in the x-ray.This report is for unknown dynamic compression plate (dcp) clavicle hook plate.This is report 9 of 10 for (b)(4).The complaint involves 16 devices.Due to a system limitation, (b)(4) captures ten (10) devices and (b)(4) captures six (6) devices.
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