MAUDE Adverse Event Report: NUVASIVE, INC. COROENT; POLYMERIC SPINAL INTERBODY FUSION CAGE

Model Number	6080828
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is unavailable for evaluation as it remains in situ.The root cause cannot be determined at this time.If any additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
Coroent peek cage fractured and was replaced during surgery.This event occurred in new zealand.
Event or Problem Description
It was reported that a coroent peek cage (8 degree, 28x9x8) broke apart when inserted into the patient.The cage was successfully removed from the inserter and then removed by surgeon in pieces.The surgeon then inserted a new cage and is confident that all of the broken cage has been removed from the patient.
Additional Manufacturer Narrative
At the time of investigation, the broken coroent large mp spacer (p/n 6080828) has not been returned.No operative notes, or photographs were provided for review.The clinical specialist reported that the peek cage broke apart when inserted into the patient.It was successfully removed from the inserter and then removed by the surgeon in pieces.The surgeon then inserted a new cage and is confident that all of the broken cage has been removed from the patient.It was reported that the procedure was completed and there was no adverse effect to the patient.Because the part was not returned for evaluation, the complaint was marked non-verifiable.Labeling review: ".Warnings, cautions and precautions the subject device is intended for use only as indicated.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.While proper selection can minimize risks." ".All implants should be used only with the appropriately designated instrument".".Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage." ".Devices should be inspected for damage prior to implantation.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." dhr review: a dhr review was unable to be performed because the lot number was not provided in the event evaluation report for this complaint.Risk review: review of the associated risk documentation determined the severity and rate of occurrence documented in this reported event do not exceed the post-mitigated severity, and failure mode probability, estimated in the risk management file.Following review, no new risks were identified.Conclusion: labeling, complaint history, and risk reviews were completed with no deficiencies, discrepancies, or adverse trends identified.The event will be used for trend data.Complaint monitoring will continue and additional action will be taken in the event that an adverse trend is identified.No additional action is planned at this time.

• Brand Name: COROENT
• Common Device Name: POLYMERIC SPINAL INTERBODY FUSION CAGE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego PA 92121
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 23053304
• Report Number: 2031966-2025-00124
• Device Sequence Number: 18314298
• Product Code: MAX
• UDI-Device Identifier: 00887517283429
• UDI-Public: 00887517283429
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: NZ
• PMA/510(K) Number: K141665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 6080828
• Was Device Available for Evaluation?: Yes
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown