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

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Paralysis (1997); Paresis (1998); Pleural Effusion (2010); Pneumothorax (2012); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Konstantinidis, l., et al (2010).Early surgery- related complications after anteroposterior stabilization of vertebral body fractures in the thoracolumbar region.Journal of orthopaedic science, 15, 178-184.This report is for unknown (ventrofix) /unknown quantity/unknown lot.(b)(4).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; konstantinidis, l., et al (2010).Early surgery- related complications after anteroposterior stabilization of vertebral body fractures in the thoracolumbar region.Journal of orthopaedic science, 15, 178-184.The purpose of this study is to identify typical complications associated with anterioposterior stabilization of vertebral body fractures surgeries.There were 208 patients, average age 41 years, range 15 -81, 77 female and 131 male.The study was from 2000 - 2006.The procedures were to repair unstable vertebral body fractures of the thoracic or lumbar spine with concomitant rupture of at least one adjacent intervertebral disc.Initial surgical procedures were performed with uss with schanz screws.The second surgery the patients had a non - synthes device or ventrofix.The author did not specify if the complications were related to the non- synthes device or ventrofix.Authors did not specify the complications experienced by male vs.Female patients.Therefore complications will be reported for both.This report refers to complications for ventrofix which include: superficial infection, deep infection, hematoma, pleural effusion, pneumothorax, total paraplegia, paraparesis, conus - cauda syndrome, compression of spinal canal, partial lesion of left brachial plexus, root disorder and revision surgeries.This is report 3 of 6 for (b)(4).This report is for a unknown ventrifix.

• Type of Device: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• 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: 5084280
• MDR Text Key: 26050631
• Report Number: 2520274-2015-15753
• Device Sequence Number: 1
• Product Code: KWQ
• 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: Pharmacist
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• 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: 08/26/2015
• 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