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

Model Number	6790225
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was received; however, photographs provided can confirm the alleged complaint.Review of the reported event identified the surgeon inadvertently contacted the implant with the awl and introduced a fracture as a result of the contact, which is considered the root cause.No additional investigation can be completed.Labeling review: "pre-operative warnings.Care should be used in the handling and storage of the coroent implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "warnings, cautions and precautions.All components should be final tightened per the specifications in the surgical technique.Implants should not be tightened past the locking point, as damage to the implant may occur.Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.".
Event or Problem Description
During a spinal fusion procedure, the surgeon utilized an awl which resulted in the already placed interbody fracturing at the lateral, screw side of the implant.All pieces of the fractured interbody were removed from the patient a new interbody of the same size was successfully placed.There was no patient or user harm reported in association with this event.No additional information is available.

• Brand Name: NUVASIVE COROENT SMALL INTERLOCK SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15033199
• Report Number: 2031966-2022-00094
• Device Sequence Number: 14737213
• Product Code: OVE
• UDI-Device Identifier: 00887517361608
• UDI-Public: 887517361608
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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
• Device Model Number: 6790225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AWL (PN (B)(6))
• Patient Sex: Prefer Not To Disclose