MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 25MM LORDOTIC TITANIUM SHELL; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	FHTGCT0925TTS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that that a flarehawk11 lordotic shell 25 mm fractured in two upon insertion.The shell was removed and a new one was used.There was no patient impact; however, there was an approximate five-minute delay to replace it.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.A review of the dhr was conducted and found no indications of manufacturing issues.The device was not returned, and no photos were provided so an evaluation is unable to be performed.This event likely cannot be attributed to manufacturing or design related issues.The complaint is unrefuted for tihawk shell lord 25mm tih11 ster for the failure of fracture.The failure is believed to be attributed to improper sizing of the implant because a review of stm 00018 (f) flarehawk9, tihawk9, and tihawk11 surgical technique manual includes the following direction: "it is advisable that the surgeon not deliberately select an implant that is oversized relative to the disc space.If an implant height larger than appropriate for the disc space is used, increased resistance may be encountered when expanding and locking the implant which could result in failure to lock and/or implant fracture".This device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that that a flarehawk11 lordotic shell 25mm fractured in two upon insertion.The shell was removed and a new one was used.There was no patient impact; however, there was an approximate five minute delay to replace it.

• Brand Name: 25MM LORDOTIC TITANIUM SHELL
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 23304171
• Report Number: 3012447612-2025-00324
• Device Sequence Number: 10193468
• Product Code: MAX
• UDI-Device Identifier: 00840200406642
• UDI-Public: (01)00840200406642(10)07230006
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K220453
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2026

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 Catalogue Number: FHTGCT0925TTS
• Device Lot Number: 07230006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2023
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic