MAUDE Adverse Event Report: CHOICESPINE, LLC BLACKHAWK TI CERVICAL SPACER SYSTEM; BLACKHAWK TI,CON,STERILE,14WX12DX7HXC

Model Number	S-TT10-1412C07
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the implant remains in the patient, the devices could not be physically assessed.However, manufacturing data and radiographs were reviewed.Based on the available evidence, interference of the adjacent hardware prevented seating of the anchor in the initial surgery.Choicespine recommends locking of the implant cam component to mitigate the risk of anchor back out.
Event or Problem Description
The cam of the blackhawk ti implant did not lock during the initial surgery.The surgeon noticed 4 weeks post op that one of the blades had backed out of the bone.The x ray image indicated that a screw in an adjacent plate had prohibited the blades from being fully deployed and not allowing the cam to lock appropriately.On (b)(6) 2025 a revision surgery was performed to remove the screw from the adjacent cervical plate to enable the blade on the blackhawk ti implant to fully deploy and allow the cam to lock.

• Brand Name: BLACKHAWK TI CERVICAL SPACER SYSTEM
• Common Device Name: BLACKHAWK TI,CON,STERILE,14WX12DX7HXC
• Manufacturer (Section D): CHOICESPINE, LLC; 400 erin drive; knoxville TN 37919
• Manufacturer (Section G): CHOICESPINE, LLC; 400 erin drive; knoxville TN 37919
• Manufacturer Contact: tracy huling ; 400 erin drive; knoxville, TN 37919 ; 8652433967
• MDR Report Key: 22730127
• Report Number: 3005819474-2025-00004
• Device Sequence Number: 9144094
• Product Code: OVE
• UDI-Device Identifier: 00840996182201
• UDI-Public: 00840996182201
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K223869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: S-TT10-1412C07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 08/06/2025
• 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 Age: 62 YR
• Patient Sex: Female