MAUDE Adverse Event Report: SYNTHES USA; PROSTHESIS, RIB REPLACEMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Insufficiency (2022)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: motoyama, e.K.Et al (2006).Effects on lung function of multiple expansion thoracoplasty in children with thoracic insufficiency syndrome: a longitudinal study.Spine, volume 31, number 3, pp 284-290.Usa article.The purpose of the study was to evaluate lung volume increases immediately following surgical expansion of thorax and how the thoracic expansions affect lung volumes longitudinally in children with thoracic insufficiency syndrome.The study population included 10 children (6 boys, 4 girls) ages 1.8-9.8 years of age (median age 4.3).Four (n=4) had prior anterior-posterior spinal fusions before the initial veptr insertion.The time span between the first and last surgery was 7-33 months (mean 22, median 23).The surgical procedure was scheduled for every 6 months, and the thorax was vertically expanded with veptrs (5-10mm at upper and lower ends) at each procedure.For children with bilateral thoracic hypoplasias, the second veptr was inserted in the contralateral thorax at subsequent surgery, usually 6 months after initial procedure.Pulmonary function tests were performed approximately every 6 months, immediately before and after the expansion thoracoplasty under general anesthesia.Complications: forced vital capacity was decreased in 4 patients following repeated veptr thoracoplasty.This is report 1 of 1 for (b)(4).This report is for an unknown veptr with unknown part and lot number.This report is for 1 device(s).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Literature citation: this report is being filed after the subsequent review of the following journal article: motoyama, e.K.Et al (2006).Effects on lung function of multiple expansion thoracoplasty in children with thoracic insufficiency syndrome: a longitudinal study.Spine, volume 31, number 3, pp 284-290.This report is for an unknown quantity of veptr with unknown part and lot numbers.(b)(6).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.

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4587285
• MDR Text Key: 16991593
• Report Number: 2520274-2015-11546
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention