MAUDE Adverse Event Report: DEPUY SYNTHES SPINE DISCOVER ARTIFICIAL DISC; UNKNOWN

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Failure of Implant (1924); Injury (2348)

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: skeppholm, m., lindgren, l., henriques, t., vavruch, l., löfgren, h., & olerud, c.(2015).The discover artificial disc replacement versus fusion in cervical radiculopathy¿a randomized controlled outcome trial with 2-year follow-up.The spine journal, 15(6), 1284-1294.Submitted: august 19, 2014 accepted: december 30, 2014.N=3 three cases a nonoptimal implant positioning - adverse event; n=2 two cases suspected implant instability or loosening; n=1 wound infection; n=1 postoperative hematoma* leading to reoperation.

• Brand Name: DISCOVER ARTIFICIAL 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: 6568266
• MDR Text Key: 75209875
• Report Number: 1526439-2017-10361
• Device Sequence Number: 1
• Product Code: MJO
• 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

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other