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

Model Number	6770815CP2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 a patient underwent an anterior cervical interbody fusion procedure on unknown levels of the spine.During the procedure during implant insertion the cage cracked down the middle.It is unknown whether the cracked device remained in-situ or was removed from the patient.No injury or adverse effects to the patient were reported.
Additional Manufacturer Narrative
No product was returned and no radiographs or other information was provided confirming the alleged incident.Multiple attempts were made to obtain additional information from the involved reported with no response.Due to a complete lack of information the route cause of the event could not be determined however, excessive screw angulation, off centered placement and implant selection were identified as possible cause or contributors.No additional investigation can be completed.Label review: "warnings, cautions and precautions - correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant." "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.For sterile implants: assure highly aseptic surgical conditions, and use aseptic technique when removing the coroent implant from its packaging.Inspect the implant and packaging for signs of damage, including scratched or damaged devices or damage to the sterile barrier.Do not use the coroent implants if there is any evidence of damage.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.".

• 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 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: 14691770
• Report Number: 2031966-2022-00098
• Device Sequence Number: 5327347
• Product Code: OVE
• UDI-Device Identifier: 00887517812452
• UDI-Public: 887517812452
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K170961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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: 6770815CP2
• 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: 04/20/2022
• Initial Report FDA Received Date: 06/15/2022
• 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
• Patient Sex: Prefer Not To Disclose