MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11 CC; CONFIDENCE CEMENT, BONE, VERTEBROPLASTY

Catalog Number 283910000

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Diminished Pulse Pressure (2606)

Event Date 05/01/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).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

(b)(6) notified complaint department of a case on the west coast in which a patient passed away while using depuy spine products.(b)(6) to reach out to rep for details.Per complaint form: revision scoliosis surgery.Complex patient.Lost motors during initial surgery one year ago.Recovered but deformity worsened.Instrumentation revised with cement screw augmentation.Surgeon aware of off label use of product.Correction achieved, then patient dropped motors and blood pressure.Laminectomy performed, cement present in canal.Pressure continued to drop and emergency closure done.Cpr unsuccessful and patient expired in operating room.

• Brand Name: CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11 CC
• Type of Device: CONFIDENCE CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6596345
• MDR Text Key: 76123406
• Report Number: 1526439-2017-10395
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2017
• 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?: No
• Date Manufacturer Received: 05/01/2017
• 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): Death; Other
• Patient Age: 11 YR