This report is for an unknown plate/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.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.
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This report is being filed after the review of the following journal article: marazzi c., wittauer m., hirschmann m., testa5 e., (2020) minimally invasive plate osteosynthesis (mipo) versus open reduction and internal fixation (orif) in the treatment of distal fibula danis-weber types b and c fractures, journal of orthopaedic surgery and research volume 15: pages 1-9 (switzerland).Https://doi.Org/10.1186/s13018-020-02018-5.Between 2010 and 2014, patients who underwent surgery using orif or mipo for the treatment of distal fibula fractures were consecutively included in this study.In total, 70 patients matched the inclusion criteria and were finally included in the present study.These patients were divided into two groups according to the operative technique used.For both, open reduction and internal fixation (orif) and minimally invasive plate osteosynthesis (mipo), the surgical recommendations of the ao foundation were strictly followed.In the orif group with 35 patients (12 males, 3 females) age at injury was 52.2 ± 11.3 years , depending on the fracture morphology and bone quality, either a 1/3 tubular plate (depuy synthes, oberdorf, switzerland), a 1/3 tubular locking compression plate (lcp) (depuy synthes, oberdorf, switzerland), a sidewinder plate system (trimed, santa clarita, california), or a preformed distal fibula lcp (depuy synthes, oberdorf, switzerland) was used.In the mipo group with 35 patients (17 males , 18 females ) age at injury was 54.8 ± 17.6 years , the correct dimension of the plate (in these cases only lcp 1/3 tubular plate or preformed distal fibula lcp) was chosen based on preoperative radiographic planning.Clinical and radiographic follow-up was done 6 weeks, 3 months, 6 months, and 1 year after surgery.The following complications were reported as follows: 9 postoperative pain at the 1-year follow up (n = 2 severe, n = 3 moderate, n = 4 low pain) in the orif group.2 non union in the orif group.7 superficial and deep wound infection in the oruf group.1 vascular-nerve injuries.6 postoperative pain at the 1-year follow up (n = 2 moderate, n = 4 low pain) in the mipo group.3 superficial and deep wound infection in the mipo group.This report is for an unknown synthes 1/3 tubular locking compression plate (lcp) this is report 3 of 6 for (b)(4).
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