MAUDE Adverse Event Report: NUVASIVE, INC. COROENT INTERLOCK SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	6791714
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A radiograph was received confirming the screw fracture.The patient is asymptomatic and requires no intervention.No plan for revision procedure at this time, patient will continue to be monitored.It is unknown if the patient followed post-operative restrictions and suffered a fall.The root cause of this reported event is unknown and no further investigation can be completed.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)." ".Contraindications include, but are not limited to: patients who are unwilling to restrict activities or follow medical advice." "patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.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." ".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." left in-situ.
Event or Problem Description
On (b)(6) 2016 a patient underwent a self-fixating interbody replacement procedure without any reported issues.On (b)(6) 2016 during a routine post-index procedure a follow up radiographs showed the inferior c4-5 level screw had fractured.The patient is asymptomatic no revision procedure is planned at this time.

• Brand Name: COROENT INTERLOCK SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7051410
• Report Number: 2031966-2017-00172
• Device Sequence Number: 16423668
• Product Code: OVE
• UDI-Device Identifier: 00887517362414
• UDI-Public: 00887517362414
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/21/2017

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: 6791714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR