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

Model Number	5991425
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation nor were radiographs provided to confirm the reported event.Eventhough root cause cannot be determined, information suggests implant selection may have contributed to the reported event.Labeling review: ".The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants." ".Based on fatigue testing results, when using the monolith corpectomy system, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system.".
Event or Problem Description
On (b)(6) 2017 a patient underwent a vertebral body replacement procedure at l4-l5 levels.During the two week follow up radiographs revealed a gap between the end cap of the implant and the vertebral body.On (b)(6) 2017 a revision procedure took place where the 25 mm implant was replaced with a 27 mm implant.No patient injury or product malfunction reported.

• Brand Name: NUVASIVE PEEK CORPECTOMY RAILED SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6974501
• Report Number: 2031966-2017-00148
• Device Sequence Number: 1117734
• Product Code: MQP
• UDI-Device Identifier: 00887517677228
• UDI-Public: 00887517677228
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K151538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2017

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
• Operator of Device: Physician
• Device Model Number: 5991425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 50 YR