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

Device Problem Break (1069)

Patient Problem Sedation (2368)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article.Novel titanium constructs for chest wall reconstruction in children.Jacob t.Stephenson, kit song, jeffrey r.Avansino, andrew mesher, john h.T.Waldhausen.Journal of pediatric surgery (2011) 46, 1005¿1010.The literature article is attached to this medwatch.This article is a retrospective chart review of all children and adolescents undergoing chest wall reconstruction with titanium constructs between (b)(6) 2005 and (b)(6) 2010.The study is a retrospective chart review of six patients undergone chest wall reconstruction with vertical expandable prosthetic titanium rib (veptr) or other titanium constructs.Four (4) had chest wall resection for primary malignancy, one (1) had metastatic chest wall tumor resection, and one (1) had congenital chest wall deformity.There were no immediate complications, and all patients have exhibited excellent respiratory function with no scoliosis.However, 2 patients had post-operative complications.In a (b)(6) girl, during 4 year follow-up, one of the intramedullary titanium wires was found fractured but was asymptomatic and was left in place.A (b)(6) boy did required reoperation for removal of a symptomatic broken intramedullary wire.This is report 2 of 2 for complaint (b)(4), for reportable malfunction requiring intervention for (b)(6) boy.

Manufacturer Narrative

Novel titanium constructs for chest wall reconstruction in children.Journal of pediatric surgery (2011) 46, 1005¿1010.This report is for unknown veptr construct.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: COMMON NAME PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3776494
• MDR Text Key: 4377753
• Report Number: 2520274-2014-11085
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2014
• 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
• Patient Age: 10 YR