MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT THORACOLUMBAR IMPLANTS; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC

Model Number	5214402
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Paresis (1998)
Date of Event	09/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device has been returned for evaluation.It is unknown if patient has neurologic condition which may have affected neuromonitoring.Radiographs were received confirming the malplacement of the initial implant.Action to correct malplacement included placement of a smaller interbody device.The root cause of this reported event is unknown; however, review of the radiographs and operational notes indicated suboptimal interbody placement related to implant size selection or anatomical characteristics of the patient.There is no plan for revision, and the patient will continue to be monitored to determine if the paresis condition resolves.
Event or Problem Description
On (b)(6) 2016 an interbody device was inserted at l4l5.Intra-operative lateral and ap radiographs showed the device was lateral to the disc space and required adjustment.The cage was replaced with a smaller interbody implant and the case was completed without further difficulties.On 09/06/2016 a neural motor deficit of the patient's left foot was reported.

• Brand Name: NUVASIVE COROENT THORACOLUMBAR IMPLANTS
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 5998846
• Report Number: 2031966-2016-00072
• Device Sequence Number: 698441
• Product Code: PHM
• UDI-Device Identifier: 00887517629463
• UDI-Public: 00887517629463
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2016

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: 5214402
• Device Lot Number: DR7123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2016
• Initial Report FDA Received Date: 10/04/2016
• 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: Other