MAUDE Adverse Event Report: DEPUY SYNTHES SPINE HIGH VISC SPINAL CEMENT, 11CC; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 183901000

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2014

Event Type  malfunction  

Event Description

Per international affiliate, the physician reported that product has frozen 1 minute after connection/mixing cement with solvent (has been mixed about 1 minute).Clarification revealed that that the high viscosity cement within the confidence kit had set up too fast.Another confidence kit and its cement were opened and the procedure was completed with a delay of about ten minutes with no adverse consequences to the patient.

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.Device discarded.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HIGH VISC SPINAL CEMENT, 11CC
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): TEKNIMED SAS; vic en bigorre 6550 0; FR 65500
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 4243316
• MDR Text Key: 5045175
• Report Number: 1526439-2014-12076
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 183901000
• Device Lot Number: 043D13411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/04/2014
• Initial Date FDA Received: 11/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2014
• 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
• Treatment: CONFIDENCE KIT, 283913000