MAUDE Adverse Event Report: CHOICESPINE, LLC BLACKHAWK TI CERVICAL SPACER SYSTEM; BLACKHAWK TI,LOR,STERILE,14WX12D

Model Number	S-TT10-1412606
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.Took x-ray images of patient at follow-up appointment when it was noticed that the locking plate became detached from the implant.Dr.Revised the patient on (b)(6) 2026 by placing a plate over the cage and removing the detached locking plate from the patient.

• Brand Name: BLACKHAWK TI CERVICAL SPACER SYSTEM
• Common Device Name: BLACKHAWK TI,LOR,STERILE,14WX12D
• 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: 24877114
• Report Number: 3005819474-2026-00002
• Device Sequence Number: 21341884
• Product Code: OVE
• UDI-Device Identifier: 00840996182133
• UDI-Public: 00840996182133
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K203311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 04/14/2026

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-TT10-1412606
• Device Lot Number: 11144-07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/14/2026
• 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 Age: 75 YR
• Patient Sex: Female