MAUDE Adverse Event Report: CHOICESPINE, LLC CHOICESPINE TIGERSHARK M, MODULAR INTERBODY SYSTEM; TIGERSHARK M, STERILE, SPACER,28LX4H

Model Number	S-PT50-A2804
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Thank you for your feedback regarding the tigershark m implant construct.Because the spacer and endplates could not be returned, a definitive root cause for the posterior migration of the spacer could not be determined.However, based on previous investigations, it is likely that the cam did not lock properly during insertion.Design updates are currently underway to mitigate future issues with cam locking.
Event or Problem Description
On (b)(6) 2025, dr.Revised a tsm spacer and endplates implanted in the l5/s1 disc level due to posterior migration of the spacer.The patient was symptomatic resulting in the need for the revision.The patient's original surgery was on (b)(6) 2024.Dr.Performed an alif on (b)(6) 2025, removed the previously implanted tsm spacer and endplates, anteriorly, and placed a harrier sa cage in the l5/s1 disc space.The patient's original surgery was a l2 to s1 tlif with tsm devices inserted from l2 to s1.He completed the removal of the tsm implants without issue.The devices were discarded and thus cannot be sent back to choice for examination.

• Brand Name: CHOICESPINE TIGERSHARK M, MODULAR INTERBODY SYSTEM
• Common Device Name: TIGERSHARK M, STERILE, SPACER,28LX4H
• 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: 21901201
• Report Number: 3005819474-2025-00003
• Device Sequence Number: 11777021
• Product Code: MAX
• UDI-Device Identifier: 00840996188883
• UDI-Public: 00840996188883
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K220953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 04/24/2025

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-PT50-A2804
• Device Lot Number: 10455-28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/24/2025
• 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: 73 YR
• Patient Sex: Female