MAUDE Adverse Event Report: DEPUY SYNTHES SPINE UNKNOWN DISCOVER CERVICAL DISC

Catalog Number UNKNOWN DISCOVER CERVICAL DISC

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

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This complaint was generated from literature review 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 article: hou, y., liu, y., yuan, w., wang, x., chen, h., yang, l., & zhang, y.(2014).Cervical kinematics and radiological changes after discover artificial disc replacement versus fusion.The spine journal, 14(6), 867-877.Received: 21 august 2011 accepted: 10 july 2013.N=1 prevertebral hematoma and wound infection occurred in one patient.N=2 cerebrospinal fluid leak, epidural hematoma, and migration of the prosthesis were noted in two patients.

• Brand Name: UNKNOWN DISCOVER CERVICAL DISC
• Type of Device: UNKNOWN
• 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: 6568177
• MDR Text Key: 75208821
• Report Number: 1526439-2017-10357
• 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: literature
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/18/2017

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: UNKNOWN DISCOVER CERVICAL DISC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other