MAUDE Adverse Event Report: CHOICESPINE, LLC BLACKHAWK TI CERVICAL SPACER SYSTEM; BLACKHAWK TI ,LORDIC STERILE,16WX14DX8H

Model Number	S-TT10-1614608
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) was doing a acdf procedure with hardware (plate and screws) already in the patient.He expressed difficulty getting the caudal anchor impacted where the existing hardware was.The rep ( (b)(6) ) called (b)(6) while in the case and (b)(6) instructed them to use the single anchor impactor to help the blade deploy.Dr.(b)(6) was able to get both blades deployed and the cam turned for final locking.(b)(6) expressed he didn't think the cam was full locked due to how hard it was to get the anchor fully deployed.Dr.(b)(6) did a revision on the patient (b)(6) 2023 using a globus medical cage and plate.
Additional Manufacturer Narrative
Based on the information provided, it is concluded that there was likely interference of the caudal blade with adjacent hardware that caused difficulty with blade deployment and cam locking.This interference also encouraged blade back out post-operatively.On future blackawk ti cases, please ensure that the blades are fully deployed and the cam is fully locked.The confirmation of those steps in that order should result in a successful blocking of the bladed anchors.

• Brand Name: BLACKHAWK TI CERVICAL SPACER SYSTEM
• Common Device Name: BLACKHAWK TI ,LORDIC STERILE,16WX14DX8H
• 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: 17439382
• Report Number: 3005819474-2023-00007
• Device Sequence Number: 14086187
• Product Code: OVE
• UDI-Device Identifier: 00840996182270
• UDI-Public: 00840996182270
• 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: 2023
• 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): 07/10/2023

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-TT10-1614608
• Device Lot Number: 9775-030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2023
• 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: 63 YR
• Patient Sex: Male