MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE,FIXATION,SPINAL, INTERVERTEBRAL BODY

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

Patient Problem Unspecified Infection (1930)

Event Date 05/15/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for an unknown vertical expandable titanium ribs (veptr)/unknown quantity/unknown lot.The investigation could not be completed; 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.

Event Description

This report is being filed after the subsequent review of the follow article: plaass, c., hasler, c.C., heininger, u., & studer, d.(2016).Bacterial colonization of veptr implants under repeated expansions in children with severe early onset spinal deformities.Eur spine j.25:549-556.Thie countries of orgin are switzerland and germany.A study was done on 39 children with severe spinal or thoracic deformities from january 2009 to may 2012.There were 18 female patients with a mean age of 5.6 years and 21 male patients with a mean age of 9.7 years.These 39 children had 163 re-operations as part of the course of treatment with vertical expandable titanium ribs (veptr).The children were evaluated for complications associated with veptr specifically infection.After removal of veptr, the devices were microbiologically tested for signs of infection.Four patients had clinically apparent infection, which was confirmed with microbiologic testing after the schedule removal of veptr and two patients developed a clinically apparent infection during the post-operative period.This report is 1 of 2 for (b)(4).This report is for an unknown vertical expandable titanium ribs (veptr).

• Type of Device: APPLIANCE,FIXATION,SPINAL, INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5955499
• MDR Text Key: 54883775
• Report Number: 2520274-2016-14545
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H03009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2016

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 09/16/2016
• 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