MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE HIGH VISCOSITY SPINAL CEMENT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number UNK-CEMENT/CEM ACCESORY

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Unknown part number, udi is unavailable.This complaint was generated from literature review conducted in post market surveillance (pms) 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.Literature complaint.

Event Description

This report is being filed after the subsequent review of the following literature article.Li, b., wang, q., yu, y., du, w., & shao, g.(2011).Confidence high viscosity bone cement system and postural reduction in treating acute severe osteoporotic vertebral compression fractures.Zhongguo xiu fu chong jian wai ke za zhi= zhongguo xiufu chongjian waike zazhi= chinese journal of reparative and reconstructive surgery, 25(3), 307-310.(received: sep 21, 2010 revised: nov 18, 2010).N=3: cement leakage during operation.(2) into intervertebral space (1) into adjacent paravertebral soft tissue.

• Brand Name: HIGH VISCOSITY SPINAL CEMENT
• Type of Device: 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: 6751583
• MDR Text Key: 81315476
• Report Number: 1526439-2017-10620
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK-CEMENT/CEM ACCESORY
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other