MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE; CONFIDENCE CEMENT, BONE, VERTEBROPLASTY

Catalog Number UNK ¿ SPINAL IMPLANT

Device Problem Leak/Splash (1354)

Patient Problem Paraplegia (2448)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

This report is being filed after the subsequent review of the following literature article: vertebroplasty ¿ high viscosity cement versus low viscosity cement.S.Rapan1, s.Jovanovi}1, g.Gulan2, v.Boschi3, v.Kolarevi}1, t.Dap.I received for publication december 3, 2009.N=1: paraparesis caused by cement leakage into the spinal canal.

• Brand Name: CONFIDENCE
• Type of Device: CONFIDENCE CEMENT, BONE, VERTEBROPLASTY
• 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: 6875481
• MDR Text Key: 86591477
• Report Number: 1526439-2017-10746
• Device Sequence Number: 1
• Product Code: NDN
• 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: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK ¿ SPINAL IMPLANT
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• 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