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

Model Number	7180025
Medical Device Problem Codes	Collapse (1099); Device Slipped (1584)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/01/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as it remains in-situ.Radiographic images have been provided which confirm the alleged event.Warnings, cautions and precautions ".Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break." ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." remains in-situ.
Event or Problem Description
In (b)(6) 2014, a patient underwent a vertebral body replacement procedure.In a follow up exam it was discovered that the implant had experienced height loss.The patient is currently asymptomatic and there are no plans for revision surgery.

• Brand Name: NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6772800
• Report Number: 2031966-2017-00099
• Device Sequence Number: 13763979
• Product Code: MQP
• UDI-Device Identifier: 00887517426291
• UDI-Public: 00887517426291
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2017

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
• Operator of Device: No Information
• Device Model Number: 7180025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR