This report is being filed after the subsequent review of the following journal article: hessmann, m.Et al (2012, september).Internal fixation of fractures of the proximal humerus with the multiloc nail.Operative orthopadie und traumatologie, 24 (4-5), pp.418-431.Surgical technique was reported with the use of the synthes devices, multiloc humeral nail and screw, to reduce two to four part fractures of the proximal humerus.An endcap, manufacturer not specified, was also captured since the devices mentioned in this article are those of this manufacturer.The authors studied 160 patients, mean age of 65.5 years, during a six month period.Early complications included implant-related impingement and loosening of proximal locking screws in one case each.A six month follow-up was conducted with 17 patients, mean age of 67.2 years.Loss of reduction and intra articular screw penetration were reported in one case each.Radiographically, all fractures had healed.This is a reportable malfunction report for one patient with loss of reduction.This is report 7 of 8 for complaint (b)(4).This report is for an unknown multiloc nail.
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Hessmann, m.Et al (2012, september).Internal fixation of fractures of the proximal humerus with the multiloc nail.Operative orthopadie und traumatologie, 24 (4-5), pp.418-431.This report is for an unknown multiloc nail.Date unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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