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

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This report is being filed after subsequent review of the following abstract; ventura: the sagittal balance challenge in fusionless surgery: pjk predicting factors in (2014)veptr technique.Eur spine j, vol 23 (suppl 5) s499.Spain article.Clinical and radiographic data of 34 patients (mean age of 6.75) from a single center treated with vertical expandable prosthetic titanium rib (veptr) were recorded with a minimum 2-year follow-up (mean 4.5 years).Anchorage levels, proximal junctional kyphosis, coronal and sagittal balance, space available for the lung (safl) and complications were recorded before, during and after treatment.34 patients were operated from 2005 to 2011 using veptr (idiopathic: 6, neuro-muscular: 13, congenital: 12, others: 6).The incidence of pjk was seen in 12 patients (35 %).The development of pjk was associated with previous kyphosis t4¿t12 >40 degrees and proximal end vertebral selection from t5 or distally.Statistical differences were not founded in non-idiopathic patients, prior lumbar lordosis, safl or cobb angle and failure of distal segment selection.Only 3 of the 12 patients that developed pjk needed additional specific surgery to treat thoracic kyphosis.Other complications like hardware failure or progressive kyphosis were recorded.This report refers to complications; unknown hardware failure that was reported in unspecified patients.This is report 2 of 2 for (b)(4).This report is for an unknown veptr, unknown part#/lot# and unknown quantity.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).This report is for unknown veptr/unknown quantity/unknown lot.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: 4605393
• MDR Text Key: 5465241
• Report Number: 2520274-2015-11845
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: No
• 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: 02/24/2015
• 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