MAUDE Adverse Event Report: DEPUY SYNTHES SPINE TWO LEVEL PLATE, 30MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 186802030

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

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No product failure indicated.A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation 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.No product failure indicated.

Event Description

Hospital contacted complaints manager.Date of surgery (b)(6) 2017.Return to surgery (b)(6) 2017 for wash-out of surgical wound due to swelling, drainage at the site, and fever temp max 100.9°f.Cultures collected during procedure from wound tissue, fluid, and swab light growth of coag neg staph from swab only.Can you provide any general information regarding these implants, such as if there have been any reports of reactions, inflammatory or infectious, or any concerns with these items, that will be very helpful.

• Brand Name: TWO LEVEL PLATE, 30MM
• 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: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6447301
• MDR Text Key: 71322947
• Report Number: 1526439-2017-10221
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2017

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?: No
• Device Operator: No Information
• Device Catalogue Number: 186802030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention