This report is for an unknown construct/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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: gupta, r.And khanchandani, p.(2002), intercondylar fractures of the distal humerus in adults: a critical analysis of 55 cases, injury, vol.33 (6), pages 511¿515 (india).The aim of this study is to analyse the long term results of the author¿s experience of operative management of these fractures and attempts to address these problems.Between 1992 to 2000, a total of 55 patients (37 male and 18 female) with an average age of 39 years (range 18¿65 years) were included in the study.Surgery was performed using a five hole 3.5mm dcp.Maximum follow-up was 9 years with an average of 4 years.The following complications were reported as follows: 20 patients had a loss of <5° extension.15 patients had a loss of 5-10°extension.2 patients had a loss of 10-15°extension.3 patients had a loss of >15°extension.4 patients had an unacceptable (fair or poor) outcome with an arc of flexion at elbow being <60° in two and >60° in the other two.1 patient with significant heterotopic ossification was graded as fair with a limited range of motion at the elbow (<75°).1 out of 2 patients with poor grading had pre-operative pseudarthrosis while the other one had post-operative deep infection, though both had no pain and some useful function could be performed by the limb.3 patients had ulnar nerve paraesthesias in the immediate post-operative period, which disappeared spontaneously by the third week.2 patients had early deep infection requiring the removal of implants after healing of the fracture.1 patient had late local superficial infection due to scar breakdown at the site of tension band wiring of olecranon, which healed after removal of the implants.2 patients developed heterotopic ossification which was clinically not significant in view of the fact that it did not interfere markedly with the range of motion.1 patient had a clinically apparent cubitus varus deformity but without any interference in elbow function.A male patient had a significant heterotopic ossification.This report is for an unknown synthes dynamic compression plate/screws constructs.This is report 1 of 2 for (b)(4).A copy of the literature article is being submitted with this medwatch.
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