MAUDE Adverse Event Report: NUVASIVE, INC. COROENT INTERLOCK SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	6791714
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	11/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as it remains in-situ.No x-rays were provided to confirm the reported event.A revision procedure has been discussed but not planned at this time.Patient is currently seeing pain management.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: permanent pain." ".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." ".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." ".Patient education: 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." product remains in-situ.
Event or Problem Description
On (b)(6) 2016 patient underwent an anterior cervical discectomy and fusion procedure at c5-c6 levels.During the 6 month visit a flexion/extension radiograph showed a broken screw at c6.As per reporter surgeon noted potential pseudoarthrosis at c6-c7 levels.Patient is currently seeing pain management, no revision procedure has been planned at this time.

• Brand Name: COROENT INTERLOCK SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7277088
• Report Number: 2031966-2018-00012
• Device Sequence Number: 1343440
• Product Code: OVE
• UDI-Device Identifier: 00887517362414
• UDI-Public: 00887517362414
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K102547
• 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
• Report Date (Section B): 02/16/2018

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: 01/29/2018
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR