MAUDE Adverse Event Report: NUVASIVE, INC. X-CORE VERTEBRAL BODY REPLACEMENT DEVICE; SPINAL VGERTEBRAL BODY REPLACEMENT

Model Number 6225004

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 01/10/2015

Event Type  malfunction  

Event Description

Vertebral body replacement device was implanted at l3 in (b)(6) 2014.Three locking screws reportedly broke and the core disengaged both the superior and inferior end caps.It was confirmed that the implants were disposed of by the hospital.Revision surgery was performed on (b)(6) 2015.No injury is known to have occurred.No additional details are available at this time.

Manufacturer Narrative

(b)(4).Photographs were received and the event was confirmed.The locking screws were broken and the core had disengaged from both the superior and inferior end caps.The locking screws were noted to have broken into multiple fragments.The implants were ot returned as they were discarded by the hospital.No information has been received regarding patient's activity level, or compliance with post-surgical instructions.The information suggests a fall or impact may have occurred, however root cause of the event has not been established at this time.Review of the device history record notes no material non-conformance or manufacturing errors that may have caused or contributed to this mode of failure.

• Brand Name: X-CORE VERTEBRAL BODY REPLACEMENT DEVICE
• Type of Device: SPINAL VGERTEBRAL BODY REPLACEMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: deborah silva ; 7475 lusk blvd; san diego, CA 92121 ; 8589091830
• MDR Report Key: 4512444
• MDR Text Key: 17267414
• Report Number: 2031966-2015-00001
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2015

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: Health Professional
• Device Model Number: 6225004
• Device Lot Number: BB3842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2015
• Initial Date FDA Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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): Required Intervention