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

Model Number 8594520

Device Problems Patient-Device Incompatibility (2682); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 01/17/2017

Event Type  malfunction  

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 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
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, 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: yobana sanchez ; 7475 lusk blvd; san diego, CA 92121 ; 8589093383
• MDR Report Key: 6886270
• MDR Text Key: 88228769
• Report Number: 2031966-2017-00115
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00887517322685
• UDI-Public: 00887517322685
• Combination Product (y/n): N
• PMA/PMN Number: K100043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8594520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2017
• 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