MAUDE Adverse Event Report: CHOICESPINE, LLC CHOICESPINE TIGERSHARK¿ M, MODULAR INTERBODY SYSTEM; TIGERSHARK M,STERILE,ENDPLATES,24LX6DEG

Model Number	S-PT50-E2406
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Because the spacer and endplates could not be returned, a definitive root cause for the misalignment of the spacer could not be determined.
Event or Problem Description
Dr.Implanted tsm devices in the l5/s1 and l4/l5 disc spaces on 4/21/25.He used 24 mm length, 6degree endplates (s-pt50-e2406; lot 11861-03).He used a 2mm spacer (s-pt50-a2402; lot 10455-19) in the l4/5 disc space and a 3mm spacer in the l5/s1 disc space.Postoperative images taken at the end of the case showed misalignment of the inferior tsm endplate and the tsm spacer.At a later date, dr.Decided to revise the hardware and completed a revision surgery for this patient on (b)(6) 2025.The tsm cage was removed and replaced with a different interbody.The removed implants were discarded.

• Brand Name: CHOICESPINE TIGERSHARK¿ M, MODULAR INTERBODY SYSTEM
• Common Device Name: TIGERSHARK M,STERILE,ENDPLATES,24LX6DEG
• 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 37919 ; 8652433967
• MDR Report Key: 22898146
• Report Number: 3005819474-2025-00005
• Device Sequence Number: 20284321
• Product Code: MAX
• UDI-Device Identifier: 00840996188791
• UDI-Public: 00840996188791
• 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 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): 08/26/2025

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
• Device Model Number: S-PT50-E2406
• Device Lot Number: 11861-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/26/2025
• 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: 68 YR
• Patient Sex: Female