MAUDE Adverse Event Report: Blackhawk Ti Cervical Spacer System; Blackhawk Ti Lor, Ste 14Wx12Dx6H

Model Number	S-TT10-1412606
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was complaining of pain in c3/4 disc.Upon xray it was noticed that the other levels with implants had blades backing out.2/3 levels have blades backing out.
Additional Manufacturer Narrative
Because the implant could not be returned, and due to the limited information available regarding the surgical procedure, a definitive root cause for anchor back out could not be determined.Complaints of this nature have been implemented to address and mitigate the possible user error and assembly failure modes that may contribute to this concern.The failure model is actively being monitored.

• Brand Name: Blackhawk Ti Cervical Spacer System
• Common Device Name: Blackhawk Ti Lor, Ste 14Wx12Dx6H
• Manufacturer Contact: tracy huling ; 400 erin drive; knoxville, TN 37919 ; +1(865)243-3967
• MDR Report Key: 50126973
• Report Number: 3005819474-2026-00004
• Device Sequence Number: 5674984
• 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: K171489
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: 9937-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 70 YR
• Patient Sex: Female