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	Pain (1994)
Date of Event	07/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiograph was received and confirmed the event.Revision surgery has not occurred.No further investigation can be completed at this time.The root cause of this reported event has not been determined; no conclusion can be drawn.Trend review indicates no adverse trend exists for the fault type.Review of labeling notes: "potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation, nonunion or delayed union, fracture of the vertebra.".
Event or Problem Description
On (b)(6) 2016, a patient underwent a two-level (c5-c6 and c6-c7) acdf with peek implants and integral screws directed cranially and caudally at each implant.Four months postoperative, the patient reported experiencing some pain.Radiographs were performed and noted the cranially directed screw at c5-c6 broke approximately midway along the shank.Revision surgery has not occurred.

• 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: 5988533
• Report Number: 2031966-2016-00071
• Device Sequence Number: 16271105
• 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): 09/29/2016

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: 6791714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2016
• Initial Report FDA Received Date: 09/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1