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); Pain (1994); Pneumonia (2011); Pneumothorax (2012); Respiratory Distress (2045); Respiratory Tract Infection (2420)

Event Date 05/20/2009

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following literature article samdani, a.& et al.(2010).The usefulness of veptr in the older child with complex spine and chest deformity.Clin orthop relat res (468) 700¿704.Ten patients with assorted diagnoses who underwent surgery after age 10 and had a minimum of 24-month follow-up (mean, 39.6 months; range, 24¿75 months) were retrospectively identified from a database of 214 patients treated in a food and drug administration investigational device exemption study of vertical expandable prosthetic titanium rib (veptr).Patients underwent an average of five lengthenings.The mean preoperative cobb angle was 64.7°and improved to 48.4°.Head shift improved an average of 3.8 cm.One patient died of respiratory failure at 1.5 years after initial veptr surgery.This patient had undergone veptr placement at age 11 with a subsequent spinal fusion 1 year later.He died shortly after the spinal fusion from pulmonary complications (this patient was not included in the analysis).Six of the 10 patients experienced adverse events.Two device-related complications occurred (both in the same patient).Device-related adverse events included one patient with device fracture and migration (separate episodes) and one patient who experienced pain in the upper lumbar spine, which subsided without intervention.Other adverse events reported include two patients with pneumonia, one patient with respiratory issues resulting from a pneumothorax, and one patient with respiratory infection.No neurologic complications were seen in any patients.It was the conclusion of the author¿s that for a select group of patients 10 years of age or older, the veptr offers a reasonable alternative to potentially risky vertebral column resections for correcting deformities in selected patients.Four patients have since undergone definitive spinal fusion.This is report is for an unknown number of veptr implants regarding adverse events (infection, pain, pneumonia, respiratory issues, pneumothorax, respiratory infections).This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Samdani, a.& et al.(2010).The usefulness of veptr in the older child with complex spine and chest deformity.Clin orthop relat res (468) 700¿704.This report is for unknown veptr/unknown quantity/unknown lot.(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 east; west chester, PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4591963
• MDR Text Key: 16467224
• Report Number: 2520274-2015-11584
• 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,Health Professional
• 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