Group ii consisted of 6 patients (1 male 5 female) with an average age at the beginning of the treatment was 4 (range: 1.6-6.6) years, were treated with veptr technique.This report is for an unknown veptr ala hook/unknown lot.Part and lot number are unknown; udi 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.(b)(4).
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This report is being filed after the review of the following journal article: atici, y., akman y., balioglu m., erdogan s.(2015), a comparison of the effects of two different techniques on shoulder balance in the treatment of congenital, journal of craniovertebral junction & spine (2015) volume 6(4),pages 190-194 (turkey).This study aims to evaluate how the two different growth guidance techniques radiologically effect on shoulder balance in the treatment of congenital scoliosis.Between 2004 to 2011, a total of 13 patients (2 male 7 female) with congenital scoliosis who underwent operation were included in the study.These patients were divided into 2 groups.Group i consisted of seven patients (1 male 6 female) with an average age at the beginning of the treatment was 7.5 (range: 4.6-10) years, were treated with a dual growing rod.Group ii consisted of 6 patients (1 male 5 female) with an average age at the beginning of the treatment was 4 (range: 1.6-6.6) years, were treated with veptr technique.The average follow-up periods for group 1 and group 2 were 4.2 (range: 2-7) years and 4.7 (range: 2-6) years, respectively.The following complications were reported as follows: group 2: 5 of the 6 patients had these complications consisted of: 3 cases of proximal cradle migrations.3 cases of distal cradle migrations.2 cases of hook displacement.2 cases of deep wound infection.1 case of rod fracture.This report is for an unknown veptr ala hook.This is report 3 of 6 for (b)(4).
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