MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 6908855

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Perforation (2001)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation and no radiographs or photographs provided to confirm the reported event.Similar events have been associated with implant size selection, insufficiently distracted / prepared disc space and/or high impaction force.The patient has recovered and is doing well.Labeling review: ".Based on fatigue testing results, when using the coronet thoracolumbar system, the physician should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system.Care should be taken to insure that all components are ideally fixated prior to closure.All components should be final tightened per the specifications in the surgical technique.Implants should not be tightened past the locking point, as damage to the implant may occur.All implants should be used only with the appropriately designated instrument (reference surgical technique." left in-situ.

Event Description

On (b)(6) 2018 a patient underwent an extreme lateral interbody fusion procedure utilizing a coronet xl interbody device and inserter.The interbody implant became lodged in the l3-l4 disc space.Impaction force was applied to advance the implant; the cage fractured into several pieces at the inserter/implant engagement.The inserter plunged anteriorly damaging the segmental artery.The surgeon was able to control the bleeding with gauze packing, removed the pieces of cage and complete the procedure with no complication.Estimated blood loss is not known; however, blood transfusion was reportedly not required.

• Brand Name: NUVASIVE COROENT SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 7375612
• MDR Text Key: 103673532
• Report Number: 2031966-2018-00025
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00887517389718
• UDI-Public: 00887517389718
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 6908855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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