MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE SPINAL CMT SYS, 11C; CONFIDENCE CEMENT, BONE, VERTEBROPLASTY

Catalog Number 283910000

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

Patient Problem Reaction (2414)

Event Date 12/11/2014

Event Type  Injury  

Event Description

Dr (b)(6) was treating an elderly woman with a severe compression fracture at t12.Dr (b)(6) injected approximately 10cc of the confidence cement into each vertebral body (t10, l1, l2) using a 10 gauge jamshidi needle which is included in the confidence kit.Dr (b)(6) used a bi-pedicular approach in which he injected approximately 5cc per pedicle under constant fluoroscopy.The cement deployed appropriately and was contained within the vertebral bodies.Dr (b)(6) then placed pedicle screws at t10, t11, l1 and l2 using screws from lanx spine.Very shortly after the final pedicle screw was placed, the patient's blood pressure began dropping quickly.At that point, i left the room to allow the professional medical staff to treat the patient.It is my understanding that the patient 'coded' but was brought back and made it to recovery.

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.Remains implanted.

• Brand Name: CONFIDENCE SPINAL CMT SYS, 11C
• 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: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 4391319
• MDR Text Key: 18926904
• Report Number: 1526439-2015-10013
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 283910000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/11/2014
• 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): Life Threatening; Required Intervention
• Patient Age: 76 YR