MAUDE Adverse Event Report: GLOBUS ACADIA; SYSTEM, FACET SCREW SPINAL DEVICE

Device Problem Device Inoperable (1663)

Patient Problem Test Result (2695)

Event Date 03/26/2014

Event Type  Injury  

Event Description

Pt underwent lumbar fusion surgery l4-5 involving use of acadia (globus) ide.Post-operatively several months, pt reported no improvement in symptoms to implanting surgeon.Though repeatedly told that there were no device failures, in 2017 pt notified (b)(6) and was informed the device had failed.Imaging testing revealed non-fusion and blood testing revealed toxic cobalt levels 12.1 when normal is 1.9.No disclosure of actual device-risks were made and sponsor/surgeon did not disclose device-related failure to fda or in the clinical data (b)(4).

• Brand Name: ACADIA
• Type of Device: SYSTEM, FACET SCREW SPINAL DEVICE
• Manufacturer (Section D): GLOBUS
• MDR Report Key: 7221362
• MDR Text Key: 98516232
• Report Number: MW5074873
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 61