MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SKYLINE PLATE; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395)

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Unspecified Infection (1930); Neck Pain (2433); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Udi: unavailable.This complaint was generated from literature review conducted in post market surveillance (pms) for health authority reporting purposes.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the pms identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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 abstract laster, j et al (2014) an atypical case of melena caused by esophageal perforation the american journal of gastroenterology pg 120 united states.(b)(4).

• Brand Name: SKYLINE PLATE
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5480859
• MDR Text Key: 39697540
• Report Number: 1526439-2016-10174
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 54 YR