MAUDE Adverse Event Report: CHOICESPINE, LLC CHOICESPINE TIGERSHARK M, MODULAR INTERBODY SYSTEM; TIGERSHARK M, STERILE, SPACER,32LX5H

Model Number	S-PT50-A3205
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After analyzing the returned spacer and endplate, signs of deformation were observed on the cam component which confirmed that the cam experienced unintentional interference with the endplate.
Event or Problem Description
Dr.Performed an l4 to s1 posterior decompression and fusion with tlif l4/l5 using the tsm implants on (b)(6) 2024.On (b)(6) 2025, i received x-rays and a notification of his intent to revise the patient due to posterior migration of the s-pt50-a3205 (32x5mm) spacer.On (b)(6) 2025, dr.Performed the revision surgery.He made his incision and exposed the posterior aspect of the tsm spacer.He first attempted to mallet it anteriorly.The spacer did not move with respect to the tsm endplates.He then used the tsm spacer removal instrument with the slap hammer.After several attempts, he was able to remove the tsm spacer from the tsm endplates and from the patient.He was then able to use a pituitary to grab the tsm endplates and remove them.He implanted a 32mm (length) x 11mm (width) x 14mm (height), 6-degree tigershark straight cage in the disc space where the tsm implants were removed.He compressed on the cage using the pedicle screws.
Event or Problem Description
Dr.Performed an l4 to s1 posterior decompression and fusion with tlif l4/l5 using the tsm implants on (b)(6) 2024.On (b)(6) 2025, i received x-rays and a notification of his intent to revise the patient due to posterior migration of the s-pt50-a3205 (32x5mm) spacer.On (b)(6) 2025, dr.(b)(6) performed the revision surgery.He made his incision and exposed the posterior aspect of the tsm spacer.He first attempted to mallet it anteriorly.The spacer did not move with respect to the tsm endplates.He then used the tsm spacer removal instrument with the slap hammer.After several attempts, he was able to remove the tsm spacer from the tsm endplates and from the patient.He was then able to use a pituitary to grab the tsm endplates and remove them.He implanted a 32mm (length) x 11mm (width) x 14mm (height), 6-degree tigershark straight cage in the disc space where the tsm implants were removed.He compressed on the cage using the pedicle screws.

• Brand Name: CHOICESPINE TIGERSHARK M, MODULAR INTERBODY SYSTEM
• Common Device Name: TIGERSHARK M, STERILE, SPACER,32LX5H
• 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: 21830011
• Report Number: 3005819474-2025-00002
• Device Sequence Number: 9301019
• Product Code: MAX
• UDI-Device Identifier: 00840996188968
• UDI-Public: 00840996188968
• 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,Followup
• Report Date (Section B): 04/30/2025

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-A3205
• Device Lot Number: 10492-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male