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

Model Number	7151055
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were received and the event was confirmed.The implant remains in-situ.No revision surgery has occurred.The root cause is unknown; however, it may be the result of a possible non-union at l3-l4.No further investigation can be conducted at this time.Review of labeling notes: potential adverse events and complications: "potential risk identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss fixation, nonunion or delayed union." warnings, cautions and precautions: "these devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant." device remains in-situ.
Event or Problem Description
Patient underwent a lateral interbody fusion procedure at l3-4 on (b)(6) 2016.A peek interbody cage was implanted with additional fixation hardware.In addition, a bone graft was placed inside the cage and in the posterior lateral gutters.One year after index surgery, radiographs indicated l3-4 had not fused and the cage migrated anteriorly.The patient reported severe pain.No injury was reported.
Additional Manufacturer Narrative
Received additional information indicating patient underwent a revision surgery.During the revision surgery it was confirmed the anterior longitude ligament (all) was not compromised.Product has not returned for investigation.

• Brand Name: NUVASIVE COROENT SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC; 7475 luks blvd; san diego CA 92121
• MDR Report Key: 6509947
• Report Number: 2031966-2017-00034
• Device Sequence Number: 16508347
• Product Code: MAX
• UDI-Device Identifier: 00887517231703
• UDI-Public: 00887517231703
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2017

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: No Information
• Device Model Number: 7151055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OSTEOCEL PRO CELLULAR BONE MATRIX