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

Model Number	4119308P2
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cohere cage was broken intraoperatively, it was removed and replaced.This event occurred in hong kong.
Additional Manufacturer Narrative
The device has not returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Additional Manufacturer Narrative
The investigation revealed a reported cohere tlif-a cage was broken after impact to patient, and inserter is normal function with another cage.No spacer or no photographs of the device were provided for review.Additionally, no radiographs or operative notes were provided for review of usage/technique.Based on the information available, the complaint was unable to be verified, and the cause of the reported event was unable to be determined conclusively.However, possible off-angled excessive force applied during impaction, in-situ twisting, as well as overtightening of the implant on the inserter may have caused or contributed to the reported breakage.A labeling review was completed.A dhr for lot n349610 was unable to be located and therefore a dhr review was unable to be completed.A risk review was completed.Review of the associated risk for cohere tlif-a product family determined that the hazards associated with the reported event were previously addressed and mitigated and the severity of possible effects do not exceed those estimated in the risk documentation.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.No adverse trend was identified, and the complaint does not justify the need for new or additional risk evaluation.
Event or Problem Description
The cage is broken after impact to the patient, and the inserter is able to function normally with another cage.No adverse effect to patient.

• Brand Name: COHERE
• Common Device Name: POLYMERIC SPINAL INTERBODY FUSION CAGE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 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: 22938187
• Report Number: 2031966-2025-00117
• Device Sequence Number: 9919630
• Product Code: MAX
• UDI-Device Identifier: 00887517022035
• UDI-Public: 00887517022035
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: HK
• PMA/510(K) Number: K181860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/02/2026

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: 4119308P2
• Device Lot Number: N349610
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 04/02/2026
• 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
• Patient Sex: Unknown