This report is for an unknown screws for precontoured 3.5 mm lcp olecranon plate/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: laun r., et al (2015), monteggia-like lesions ¿ treatment strategies and one-year results, gms interdisciplinary plastic and reconstructive surgery dgpw, volume 4, doc 13, pages 1-8 (germany).Doi: 10.3205/iprs000072.This retrospective study aims to better define circumstances and patterns of injury and to document the short term results of treatment with current fixation techniques.Between 2012 and 2014, a total of 10 patients (4 male and 6 female) with an average age of 52.4 years (range, 18¿83 years) who underwent surgical treatment for a monteggia like lesion were included in the study.Osteosynthesis of the ulna was performed using a proximally contoured 3.5 mm lcp (locking compression plate) or pre-contoured 3.5 mm lcp olecranon plate (both synthes gmbh, umkirch, germany).Clinical and radiological follow-up examinations at an average of 12.3 months after the trauma were performed.The following complications were reported as follows: the average vas value was 1.0 (0 to 1) at rest and 1.7 (0 to 3) during activities.Two patients with a radial head prosthesis showed mild osteopenia and grade 1 degenerative changes.These patients exhibited grade 1 heterotopic ossifications.This report is for an unknown screws for precontoured 3.5 mm lcp olecranon plate.This is report 4 of 4 for complaint (b)(4).
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