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

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

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown veptr device.The investigation could not be completed and no conclusion could be drawn as no device was returned and no part number or lot number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following journal article.Carbon coated implants as a new solution for metal allergy in early-onset scoliosis: a case report and review of the literature.Julie zielinski, md; thomas a.Lacy, md; jonathan huw phillips, md.Spine deformity 2 (2014) 76-80.This article is a retrospective review of a case report.The patient was born with hypoplastic lungs, scoliosis, and respiratory difficulties suggestive of syndromic thoracic insufficiency.Patient presented at age 4 years 3 months with scoliosis, kyphosis, and no neurologic deficits.Consideration was given for vertical expandable prosthetic titanium rib (veptr); (synthes, inc., (b)(4)) placement to allow spinal curve stabilization and, it was hoped, salvage of pulmonary function.The child spent much of the next 2 years with gastrojejunostomy tube surgeries, management of respiratory infections, and cardiac and pulmonary optimization.At age (b)(6), a male patient underwent an uncomplicated placement of bilateral posterior vertical expandable prosthetic titanium ribs (veptrs; synthes, inc., (b)(4)).At that time, there were no known metal allergies.At 3 weeks, the right side had become erythematous and had serosanguineous drainage.It briefly improved after each of 2 surgical debridements and a course of intravenous antibiotics, but within 6 weeks of the index procedure, the pain was still worsening.A titanium allergy was suspected and blood was sent for allergy testing.A test confirmed hypersensitivity to titanium, niobium, molybdenum, iron, and aluminum, among others.The remaining rod was removed.An in vivo trial for tolerance to high-grade stainless-steel implants was done.The implant was removed after 2 weeks because of systemic symptoms that occurred.This is report 1 of 1 for complaint (b)(4) for serious injury.

• 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: 3761854
• MDR Text Key: 15876272
• Report Number: 2520274-2014-10936
• 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: Other Health Care 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: 04/21/2014
• 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: 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: 4 YR