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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 09/15/2006 |
Event Type
Injury
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Manufacturer Narrative
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Device was used treatment, not diagnosis.The report is fro an unknown distractor/unknown quantity/unknown lot.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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Event Description
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This report is being filed after the subsequent review of the following journal article, "cleft maxillary distraction versus orthognathic surgery: clinical morbidities and surgical relapse" cheung, l.K., chua, h.D.P.Hagg, m.B.(2006).American society of plastic surgeons 118:996-1008.Study conducted in china.The authors summarized the surgical experience and clinical results of 29 cleft and palate patients with moderate maxillary hypoplasia requiring a maxillary le fort i advancement of 4 to 10 mm were randomized into two groups for either internal maxillary distractors or immediate fragment transposition using miniplates and screw fixation.Results included: in the distraction group (synthes device), two of the 15 patients developed infection around the distractors and one patient had an occlusal relapse.One female patient presented with mucosal infection around the distractors during the activation period.The infection was controlled with intravenous antibiotics administered for a week.This is report 1 of 3 for (b)(4).This report is for an unknown distractor.
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Manufacturer Narrative
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Device 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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Search Alerts/Recalls
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