MAUDE Adverse Event Report: SYNTHES USA; SPINAL VERTEBRAL BODY REPLACE

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pleural Effusion (2010)

Event Date 01/25/2013

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not for diagnosis.Additional narrative: this report is for an unknown synex (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 subseqent review of the following literature article: meredith, d; et al (2013) extreme lateral interbody fusion (xlif) in the thoracic and thoracolumbar spine: technical report and early outcomes.Hssj 9: 25-31.The objective of this study was to describe our initial experience with an adaptation of the extreme lateral interbody fusion (xlif) technique allowing access to the anterior aspect of the thoracic and thoracolumbar spine with specific reference to early pulmonary complications, non-pulmonary complications, and ability of this technique to successfully achieve spinal decompression and fusion at the operative level.Clinical and radiographic data were reviewed for the entire perioperative period.A total of 18 patients (13 females, 5 males) underwent a modified xlif procedure during the time frame of the study.The mean age was 56.8 years and bmi was 25.6.The mean estimated blood loss was 577 ml and the mean length of stay was 12 days.At a mean follow-up of 14 months, all patients except for one (who died of widely metastatic disease) had achieved radiographic evidence of fusion.Two patients developed pulmonary effusions requiring medical intervention.Six patients had seven non-pulmonary complications: incidental durotomy (two), infection (one), instrumentation pullout (one), cardiac arrhythmia (two), and death from metastatic disease (one).Lateral radiographs are used to confirm that the retractor is centered over the correct interspace.This provides excellent exposure for discectomy of up to two adjacent levels or a single level corpectomy.Our preference is to use nuvasive peek cages for discectomy and synthes expandable cages (synex, (b)(4)) for corpectomy reconstruction.The xlif technique can be utilized for access to the anterior column of the thoracic and thoracolumbar spine.The advantages of this minimally invasive technique include avoidance of the need for an access surgeon and for lung deflation during surgery as well as excellent visualization of the spinal pathology.This report is 1 of 1 for (b)(4).This report is for an unknown synex system and refers to the serious injury / reportable malfunction of case 1, (b)(6) female patient who experienced delayed pleural effusion requiring chest tube reinsertion, pullout of instrumentation requiring re-operation 1 month post-operatively.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: SPINAL VERTEBRAL BODY REPLACE
• 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: 5623842
• MDR Text Key: 44147874
• Report Number: 2520274-2016-12399
• Device Sequence Number: 1
• Product Code: MQP
• 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,litera
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2016
• 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
• Patient Age: 78 YR