MAUDE Adverse Event Report: NUVASIVE, INC. X-CORE2 VERTBRAL BODY REPLACEMENT DEVICE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 7180055

Device Problem Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

A partial corpectomy of t12 and l1 was performed on (b)(6) 2014, during which a vbr plate device and lateral fixation plate were implanted.Approximately 2-3 weeks post-op, it was noted that the expandable vbr device had partially reduced in height.Revision surgery was performed on (b)(6) 2014, during which the vbr implant was re-expanded and supplemental posterior fixation was added.During revision surgery, it was noted that the superior t11 vertebral body had fractured.There is no indication that the fracture was caused by the implanted device.It is unk if the pt sustained a fall or other eternal trauma.

Manufacturer Narrative

(b)(4).No product has been explanted or returned and nuvasive has been unable to perform an analysis of the device in question.Revision surgery was performed to re-expand the vbr device, remove a lateral plate construct, and add supplemental posterior fixation to further stabilize the pt.The pt is reported to be doing well post-revision with no permanent impairment or injury.Serial radiographs were evaluated to confirm the initial report as well as to determine the degree of collapse.Review of labeling notes: "potential risks identified with the use of this devoice system, which may require add'l surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury." "internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant." "care should be taken to insure that all components are ideally fixated prior to closure.".

• Brand Name: X-CORE2 VERTBRAL BODY REPLACEMENT DEVICE
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: brett greenwald ; 7475 lusk blvd; san diego, CA 92121 ; 8583205252
• MDR Report Key: 3716815
• MDR Text Key: 4253120
• Report Number: 2031966-2014-00005
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090176
• 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: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7180055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/01/2014
• Event Location: Home
• Date Manufacturer Received: 01/28/2014
• 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