Device was used for treatment, not diagnosis.Additional narrative: (b)(4).This report is for an unknown titanium elastic nail / unknown quantity / unknown lot.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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This report is being filed after the subsequent review of the following journal article: garg s.Et al.(2016).Surgical treatment of traumatic pediatric humeral diaphyseal fractures with titanium elastic nails.J child orthop (2009) volume 3: pages 121¿127.Usa.This is a retrospective review of all traumatic humeral shaft fractures treated between 1999 and 2006.Thirteen pediatric patients (eight boys, five girls) ranging in age from 4.8 to 16.7 years (mean age 12.0 years) were treated surgically with titanium elastic nails (tens) (synthes, (b)(4)).The patients were followed for a mean of 29 months.One patient ((b)(6), male) missed his initial postoperative appointment, and when his dressing was removed 6 weeks after surgery in the clinic, both nails had migrated distally through the skin.There was no clinical evidence of infection in this patient, and the fracture was united radiographically.The nails were removed in the clinic, and the wounds left open to heal secondarily.The patient did not attend follow-up after that visit and was unable to be reached by telephone or mail thereafter.This is report 2 of 2 for (b)(4).This report is for unknown titanium elastic nail system.
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