MAUDE Adverse Event Report: NUVASIVE, INC. COROENT XLR STANDALONE SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	8594520
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation as it remains in-situ.No x-ray films were provided to confirm the reported event.Potential adverse events and complications "as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: loss of sensory and/or motor function." "potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s) pain, discomfort or abnormal sensations due to the presence of the device." product remains in-situ.
Event or Problem Description
Patient reported a potential metal sensitivity following implantation of a single-level brigade interbody device with coroent xlr-f screws.As per patient on (b)(6) 2016, a follow up visit noted loosening of screws with indication of fusion.Patient underwent a procedure on (b)(6) 2017 where supplemental fixation was described.

• Brand Name: COROENT XLR STANDALONE SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6886270
• Report Number: 2031966-2017-00115
• Device Sequence Number: 10886529
• Product Code: OVD
• UDI-Device Identifier: 00887517322685
• UDI-Public: 00887517322685
• Combination Product (Y/N): N
• PMA/510(K) Number: K100043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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: 8594520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1