This report is for an unknown 3.5 mm dcp plate/screw construct/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.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: suarez r., barquet a., fresco r.,(2016) epidemiology and treatment of monteggia lesion in adults: series of 44 cases, acta ortopedica brasileira volume 24(1), pages 48-51(uruguay).This retrospective study aims to describe the characteristics, treatment and outcome of patients with monteggia lesion from two (b)(6) institutions.Between 2006 and 2012, clinical records and radiographs of all adult patients (>18 years old) with monteggia lesion were reviewed.A total of 44 patients (27 males, 17 females) with a minimum follow-up after surgery of 18 months were identified.For the fixation of the ulnar fracture, osteosynthesis with a 3.5 mm dcp plate was performed as single implant in 30 cases, with one-third tubular plate in two cases, with 3.5 mm dcp plate and external fixators in four cases , with 3.5 mm reconstruction plate in one case and cerclage in eight cases.The following complications were reported as follows: complications 21 occurred in the first surgery: misalignment of the ulna, radio ulnar dislocation, nonunion of the ulna, necrosis of the radial head, postoperative infection, heterotopic ossification, delayed consolidation of the neck of the radius fracture, radio-ulnar synostosis, deficiency neuropathy, and posterolateral rotatory instability.15 that suffered complications needed reoperations.Four of 31 patients that had plates (dcp and reconstruction) required reoperation.While 11 out of 13 needed reoperation when a different osteosynthesis method was used.Regarding functional results these were unsatisfactory or bad in seven cases.Loosening of osteosynthesis of radial head and neck and implant loosening.This report is for an unknown synthes 3.5 mm dcp plate/ screw construct.It captures loosening of osteosynthesis of radial head and neck.This is report 2 of 3 for (b)(4).
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