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

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

Patient Problems Unspecified Infection (1930); Perforation of Esophagus (2399)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article.Esophageal rupture in a child after vertical expandable prosthetic titanium rib expansion thoracoplasty.Stefan van vendeloo, md, kees olthof, md, phd, jan timmerman, md, and adriaan mostert, md, phd.Spine volume 36, number 10, pp e669¿e672 2011, lippincott williams & wilkins.This article reports the case of an (b)(6) old boy who developed a progressive scoliosis caused by fused ribs after multiple reoperations for esophageal atresia.The patient was treated operatively by an expansion thoracoplasty via an opening wedge thoracostomy with implementation of two vertical expandable prosthetic titanium rib (veptr).After surgery, the patient developed a respiratory insufficiency because of rupture of the esophagus.The complication was treated conservatively.A second operation was needed to remove an infected veptr.The patient fully recovered after this severe complication.This is report 1 of 1 for complaint (b)(4), for unknown veptr construct, for infection and respiratory insufficiency.

Manufacturer Narrative

Esophageal rupture in a child after vertical expandable prosthetic titanium rib expansion thoracoplasty.Spine volume 36, number 10, pp e669¿e672 2011, lippincott williams & wilkins.This report is for unknown veptr construct.Unknown implant date and explant date.The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number and part number was reported.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: 3776493
• MDR Text Key: 15325198
• Report Number: 2520274-2014-11091
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 04/28/2014
• 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: 11 YR