MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM

Model Number 5962366

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 04/01/2013

Event Type  Injury  

Event Description

Following implantation of a vertebral body replacement (vbr) device spanning the c3-c7 spine levels, the patient reported increasing pain.The vbr was noted to have subsided into the c3 vertebral body approximately six weeks after surgery.Revision surgery was performed in which the anterior cervical plate was removed and vbr was replaced.The anterior cervical plate was replaced with posterior pedicle screw fixation.No malfunction of the device is known to have occurred.

Manufacturer Narrative

(b)(4).The product has not been returned for evaluation and may have been discarded at the user facility.Root cause of the event has not been identified; however, the reported event is consistent with patient-related factors as a contributor.Labeling review: "contraindications include but are not limited to:.Patients with inadequate bone stock or quality." "potential risks identified with the use of this system, which may require additional surgery, include:.Fracture of the vertebra.".

• Brand Name: NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
• Type of Device: NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: paul holbrook ; 7475 lusk blvd; san diego, CA 92121 ; 8583205285
• MDR Report Key: 4943517
• MDR Text Key: 20152564
• Report Number: 2031966-2015-00041
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 5962366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 67 YR