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

Model Number 5214402

Device Problem Malposition of Device (2616)

Patient Problem Paresis (1998)

Event Date 09/05/2016

Event Type  Injury  

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 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
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121 ; 8588825019
• MDR Report Key: 5998846
• MDR Text Key: 56443371
• Report Number: 2031966-2016-00072
• Device Sequence Number: 1
• Product Code: PHM
• UDI-Device Identifier: 00887517629463
• UDI-Public: 00887517629463
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5214402
• Device Lot Number: DR7123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2016
• 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