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

Model Number	S-TT10-1412607
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
Additional Manufacturer Narrative
Review of the provided images confirmed that the locking mechanism was disassociated from the implant body.Evaluation of the device history record identified no nonconformances or anomalies that would indicate a manufacturing-related root cause.Additionally, no information was provided regarding surgical technique or intraoperative conditions that may have affected the integrity of the locking mechanism.Therefore, a definitive root cause could not be determined.
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: 24875059
• Report Number: 3005819474-2026-00001
• Device Sequence Number: 10084405
• Product Code: OVE
• UDI-Device Identifier: 00840996182140
• UDI-Public: 00840996182140
• 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-TT10-1412607
• Device Lot Number: 12058-11
• 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: 66 YR
• Patient Sex: Female