MAUDE Adverse Event Report: SYNTHES USA; APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Device is used for treatment, not diagnosis.This is part is for an unknown schanz screw/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.

Event Description

This report is being filed after the subsequent review of the following literature article: wang w.Et al., (2011).External spinal skeletal fixation combination with percutaneous injury vertebra bone grafting in the treatment of thoracolumbar fractures.Spine, volume 36 , 606-611 (china).Purpose of the study was to develop a new technique by combining simplified percutaneous external pedicular fixator with intracorporeal bone grafting to treat thoracolumbar fractures and assess its technical safety and clinical efficacy.There were 50 consecutive patients from 2005 to 2007 ,who had single level thoracolumbar fractures with or without associated incomplete neurologic deficit.They underwent percutaneous external pedicle fixation and intracorporeal bone grafting surgery within 7 days of admission, had their implants removed after 3 months, and were prospectively followed for at least 12 months.American spine injury association grading, spinal canal encroachment, spinal cobb angle, and vertebral body height were calculated before and after surgery to assess clinical outcome.Fixator configuration consisted of an adjustable external frame and schanz screws (ao universal spine system), placed bilaterally in contiguous vertebral bodies cranial and caudal to the fractured vertebral body.This report is for an unknown shanz screw.This is report 1 of 1 for (b)(4) and refers to the following: 14 patients noted some atypical device-related pain with the fixator in situ.The pain was always far less severe than the index pain and generally did not require medication, with uniform resolution within 48 hours of device removal.Four patients experienced mild pin tract inflammation.These patients required drainage and a short course of antibiotics.

• Type of Device: APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM
• 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: 5405239
• MDR Text Key: 241273808
• Report Number: 2520274-2016-10620
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2016
• 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