MAUDE Adverse Event Report: NUVASIVE, INC. COROENT INTERLOCK SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	6791714
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A radiograph was received but did not confirm the reported event.There is no plan for revision procedure at this time.No product will be returned for evaluation as it remains in-situ, patient will continue to be monitored.Labeling review: ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." "patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." still in-situ.
Event or Problem Description
On (b)(6) 2013 a patient underwent a self-fixating interbody replacement procedure without reported issues.On (b)(6) 2015 the patient suffered a fall and experienced neck and shoulder pain.Radiograph and ct images showed the 2 screws in the interior endplate of c6 level and superior endplate of c7 level fractured at the proximal threaded portion.

• Brand Name: COROENT INTERLOCK SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7051329
• Report Number: 2031966-2017-00171
• Device Sequence Number: 13815451
• Product Code: OVE
• UDI-Device Identifier: 00887517362414
• UDI-Public: 00887517362414
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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: Physician
• Device Model Number: 6791714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR