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Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Impaired Healing (2378); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Additional narrative: skiak, e., et al (2015).Distal femoral derotational osteotomy with external fixation for correction of excessive femoral anteversion in patients with cerbral palsy.Journal of pediatric orthopedics 24: 425-432.This report is for an unknown modular rod system/external fixator/unknown quantity/unknown lot.(b)(4).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.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 literature article: skiak, e., et al (2015).Distal femoral derotational osteotomy with external fixation for correction of excessive femoral anteversion in patients with cerebral palsy.Journal of pediatric orthopedics 24: 425-432.A retrospective study was carried out on 27 ambulatory cerebral palsy (cp) patients, mean age 17.5 years, range 9-22 years; 11 patients with bilateral severe intoeing deformities underwent a supracondylar femoral osteotomy between (b)(6) 2008 and (b)(6) 2012.Mean weight of patients was 48.8 kilograms (range 29.8-75 kilograms).There were 5 girls and 22 boys included.A modular rod system external fixator was used.The aim of the study was to describe the technique, the results of the technique to evaluate bone healing time and type of complications associated.A (b)(6) male patient developed a hypertrophic non-union because of loosening of two pins owing to severe osteoporosis, and eventually achieved a solid union after revision by dynamic compression plate plating and splinting.This is report 2 of 2 for (b)(4).This report is for an unknown modular rod system/external fixator.A copy of the literature article is being submitted with this medwatch.
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Search Alerts/Recalls
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