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

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

Patient Problems Unspecified Infection (1930); Impaired Healing (2378); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following literature article; (may 31, 2005) the treatment of spine and chest wall deformities with fused ribs by expansion thoracotomy and insertion of vertical expandable prosthetic titanium rib.Emans; issue: volume 30(17s) supplement, 1 september 2005, pp s58-s68 this article reports complications that were reported in studies and prospective clinical trial of vertical expandable prosthetic titanium rib (veptr) in patients with combined spine and chest wall deformity with scoliosis and fused ribs.Also, report the efficacy and safety of expansion thoracostomy and veptr surgery in the treatment of thoracic insufficiency syndrome (tis) associated with fused ribs.The results reported concerning thirty-one patients with fused ribs and tis were treated, 4 of whom had undergone prior spinal arthrodesis at other institutions with continued progression of deformity.In 30 patients, the spinal deformity was controlled and growth continued in the thoracic spine during treatment at rates similar to normal.Increased volume of the constricted hemithorax and total lung volumes obtained during expansion thoracostomy were maintained at follow-up.Technique related complications included: patient 2-(id f) was 3 years, at the time of the event.Patient 1¿s primary diagnosis was deformity diagnosis fused ribs and congenital scoliosis.Veptr construct at 1 rib-to-rib and 1 rib-to-spine with no device migrations.Patient had adjacent eczema at the time of device lengthening which appeared to contribute to infection, that followed a routine device lengthening.One of the two devices was removed and was eventually re-implanted.The procedure related complications include: surgical site infection at lengthening; temporary explantation of one device and re- implanted.This is report 2 of 19 for (b)(4).This part data for unknown veptr, unknown quantity, part and lot number.A copy of the literature article is being submitted with this medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Emas (may 31, 2005): the treatment of spine and chest wall deformities with fused ribs by expansion thoracotomy and insertion of vertical expandable prosthetic titanium rib.Emans; issue: volume 30(17s) supplement, 1 september 2005, pp s58-s68 this report is for unknown veptr implant, unknown quantity, unknown item number, unknown lot number.Initial reporter phone number: (b)(6).(b)(4).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot and 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 east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4591306
• MDR Text Key: 5481631
• Report Number: 2520274-2015-11591
• 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: 03/11/2015
• 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
• Patient Age: 3 YR