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

Model Number	6980845
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor were radiographs provided to confirm the alleged event.It is unknown if patient complied with post-operative activities or if fusion was delayed.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).".Post-operative warnings: ".During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications.".
Event or Problem Description
On (b)(6) 2015 patient underwent an extreme lateral interbody fusion procedure.On (b)(6) 2018 migration of cage and subsidence was reported.No revision procedure has been scheduled.
Additional Manufacturer Narrative
Radiographs provided confirmed the reported event.Patient has been reported to be doing well.
Event or Problem Description
For additional information.

• Brand Name: NUVASIVE COROENT SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 7953855
• Report Number: 2031966-2018-00151
• Device Sequence Number: 16540400
• Product Code: MAX
• UDI-Device Identifier: 00887517402998
• UDI-Public: 887517402998
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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: Health Professional
• Device Model Number: 6980845
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1