MAUDE Adverse Event Report: CHOICESPINE LLC CHOICESPINE BLACKHAWK¿ TI CERVICAL SPACER SYSTEM; BLACKHAWK TI LORDOTIC STERILE 16WX14DX6H

Model Number	S-TT10-1614606
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the surgeon may not have fully deploying the anchors.The anchor backout seen may be due to insufficient or incomplete locking of the cam.If the anchors are not fully deployed, the cam will be unable to rotate to the locked position.In cases where patients have hard or dense bone, anchor deployment may require increased malleting force.Choicespine has included single anchor deployment instruments in the set that should assist in fully deploying anchors in these situations.Choicespine will continue to closely monitor clinical usage of the device.
Event or Problem Description
Dr.(b)(6) did a revision case on (b)(6) 2023 from the original case on (b)(6) 2023 (complaint (b)(4) ).Dr.(b)(6) used general hospital instrumentation to remove the blade that was backing out of the cage.He was able to get the blade fully removed while removing the blade he also removed the cam from the cage.Dr.(b)(6) left the original implant in with one blade deployed.

• Brand Name: CHOICESPINE BLACKHAWK¿ TI CERVICAL SPACER SYSTEM
• Common Device Name: BLACKHAWK TI LORDOTIC STERILE 16WX14DX6H
• Manufacturer (Section D): CHOICESPINE LLC; 400 erin drive; knoxville 37919
• Manufacturer (Section G): CHOICESPINE, LLC; 400 erin drive; knoxvile TN 37919
• Manufacturer Contact: tracy huling ; 400 erin drive; knoxville, TN 37919 ; 8652433967
• MDR Report Key: 16918268
• Report Number: 3005819474-2023-00006
• Device Sequence Number: 6805654
• Product Code: OVE
• UDI-Device Identifier: 00840996182256
• UDI-Public: 00840996182256
• Combination Product (Y/N): N
• 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): 04/13/2023

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-TT10-1614606
• Device Lot Number: 9937-80
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 74 YR
• Patient Sex: Male