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

Model Number 7180055

Device Problems Collapse (1099); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

Original vertebral replacement surgery at l1 on a (b)(6) year old male was performed on (b)(6) 2014.During a routine follow up on (b)(6) 2015, the radiograph noted that the vbr reportedly lost approximately 5 mm in height post-operatively.Revision is not planned at this time.No patient injury reported.Patient activity level, bone quality, and compliance with post-surgical instructions are unknown.

Manufacturer Narrative

(b)(4).Radiographs received confirmed the event.Device remains in-situ.Patient is asymptomatic.There is no plan for revision surgery.Device will not be returned and no further investigation can be completed at this time.Patient impact/sustained fall or other factors contributing to a failure are unknown.The root cause of this reported event has not been determined; no conclusion can be drawn.Trend review indicates no adverse trend exists for the fault type.

• Brand Name: X-CORE VERTEBRAL BODY REPLACEMENT DEVICE
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lust blvd; san diego CA
• Manufacturer Contact: peter perhach ; 7475 lusk blvd; san diego, CA 92121 ; 8589093347
• MDR Report Key: 4645429
• MDR Text Key: 19315103
• Report Number: 2031966-2015-00014
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7180055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• 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 Age: 62 YR