MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE COROENT INTERBODY; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	7151260
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned and no films have been provided confirming the alleged complaint.Review of the reported event identified the peek interbody fractured during impaction which is a known failure mode and generally related to off angle and excessive force but may also be the result of improper implant size selection and an attempt to distract the space with the interbody.No additional investigation can be completed at this time.Label 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." correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant." "based on fatigue testing results, when using the coroent xl interfixated system, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system." "pre-operative warnings - care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".
Event or Problem Description
On (b)(6) 2024 a patient underwent a lateral interbody fusion procedure on unknown levels of the spine.During insertion of the vertebral spacer it fractured.The fractured portions were retrieved from the patient and the remainder of the implant remains in situ.There were no adverse patient consequences reported.

• Brand Name: NUVASIVE COROENT INTERBODY
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: patrick yrigoyen ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 19784421
• Report Number: 2031966-2024-00180
• Device Sequence Number: 20900267
• Product Code: MAX
• UDI-Device Identifier: 00887517231796
• UDI-Public: 887517231796
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/19/2024

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: 7151260
• 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: 06/24/2024
• Initial Report FDA Received Date: 07/19/2024
• 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: Unknown