MAUDE Adverse Event Report: SYNTHES(USA); SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Perforation of Esophagus (2399); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Clarke, m.J.Et al, (2015) fusion following lateral mass reconstruction in the cervical spine.J neurosurg spine, 22:1477-9.This report is for an unknown spine (synmesh cage)/unknown quantity/unknown lot.Udi unknown part number, udi is unavailable.(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 were 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 article: clarke, m.J.Et al, (2015) fusion following lateral mass reconstruction in the cervical spine.J neurosurg spine, 22:1477-9.Usa article.This article presented 7 cases in which lateral mass reconstruction with a cage or fibular strut graft was used to provide load-bearing support, including 1 case of bilateral cage placement.A retrospective review was performed of the medical records of 7 patients who underwent lateral mass cage placement or fibular strut grafting from 2007 to 2009 at 2 academic institutions.Cages were secured with small fragment screws (synthes).Four men (57%) and 3 women (43%) with an average age of 49 years (range 16-77 years) were treated.A neoplastic process was diagnosed in all patients.Case 1: this was a (b)(6) man who presented with pain, difficulty swallowing and c-2 chordoma.He underwent posterior occiput to c-5 fusion, followed by resection of a c-2 chordoma.A cage (manufacturer not identified in article) was placed and approximately 4 months after the surgery it became dislodged.He underwent a revision of the construct and there was no loss of correction or hardware failure.Synthes small fragment screws were used to secure the cage.Complications include: cage migration, imminent airway compromise and eosophageal perforation resulting in regional infection (4 months post-op).This is report 1 of 3 for (b)(4).This report is for: unknown spine-(synmesh cage).

• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 5604355
• MDR Text Key: 43504212
• Report Number: 2520274-2016-12146
• 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
• Report Date: 04/04/2016

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
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 04/25/2016
• 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: 35 YR