MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE COROENT SMALL INTERLOCK II SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned as product is still in-situ.Radiographs confirm the alleged event.It is unknown if patient followed post-operative restrictions or suffered a fall.Patient's bone quality is also unknown nor if fusion has taken place.No root cause can be identified at this time.Labeling review: ".Potential adverse events and complications: 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." ".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." ".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." ".Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration well as to other complications.".
Event or Problem Description
On (b)(6) 2020 a patient underwent a spinal procedure.As per reporter approximately, five months post-operative the surgeon reported that an interlock screw had fractured.No patient injury reported and no revision surgery is planned.

• Brand Name: NUVASIVE COROENT SMALL INTERLOCK II SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• MDR Report Key: 10457762
• Report Number: 2031966-2020-00168
• Device Sequence Number: 11777221
• Product Code: OVE
• UDI-Device Identifier: 00887517945747
• UDI-Public: 887517945747
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR