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

Model Number	6770710CP2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received by nuvasive where the complaint was not confirmed cracked but rather completely fractured with material separation.Examination found severe damage to all three screw ports holes consistent with screw or instrument off centered approach and or excessive angulation and force suggesting the damage was technique related and could be the consequence of anatomical challenges.The fracture off material was not returned and it is unknown if it was left in-situ.No additional information was provided and no additional investigation can be completed.Labeling review: "warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." "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.Careful attention to osteophyte removal enables optimal implant placement." "pre-operative warnings: 5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "handling of the sterile implant: open the packages carefully.Take suitable measures to ensure that the implant does not come into contact with objects that could damage its surfaces.Use only the recommended instruments for implantation of the implants.Damaged implants must not be used.".
Event or Problem Description
Initially, it was reported the cage cracked intraoperatively while impacting into the disc space.There was no patient injury or adverse impact.Upon evaluation by the manufacturer of the returned cage, it was found portions of the cage were fractured off.

• Brand Name: NUVASIVE COROENT SMALL INTERLOCK SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 14522471
• Report Number: 2031966-2022-00080
• Device Sequence Number: 12378445
• Product Code: OVE
• UDI-Device Identifier: 00887517812414
• UDI-Public: 887517812414
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K192582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2022

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: 6770710CP2
• Device Lot Number: N301582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• 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: 04/27/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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: UNKNOWN SCREWS.
• Patient Sex: Prefer Not To Disclose