MAUDE Adverse Event Report: CHOICESPINE, LLC CHOCIESPINE TIGERSHARK M MODULAR INTERBODY SYSTEM; TIGERSHARK M, STERILE, SPACER,32LX4H

Model Number	S-PT50-A3204
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Thank you for your feedback regarding the tigershark m implants.An investigation was conducted to determine the root cause of the 5h spacer disassociating from the insertion instrumentation and the 4h spacer backing off the endplates.With the information provided, the 5h spacer likely disassociated from the insertion instrumentation because the spacer and instrumentation experienced high compressive loads due to the small targeted disc space.The compressive loads of the disc space were high enough to overcome the force securing the spacer to the inserter.As per the surgeon he performed, it is advised to replace the spacer with a smaller option or select a spacer one size smaller when inserting into an equilvalently tight disc space.Based on the intraoperative images of the 4h spacer, the cam did not properly secure/lock the spacer into the endplates.The perceived locking by surgeon was likely interference of the cam with the implant endplates.Cam locking requires approximately 6in-lbs of force.Additional required force is likely material interference due to misaligned implant components.Endplate updates are currently in process to increase the cam pocket size, allowing more clearance for the cam to lock to the endplates and mitigating the risk of this occurance.The root cause of the 4h spacer posterior migration is an unlocked cam component.It is understood that it is at the discretion of the user to determine the best treatment for their patient.In the case where cam locking is not confirmed, it is advised to confirm locking or replace implant components for optimal implant performance.Ensuring a locked cam will significantly reduce the risk of spacer back out from the implant endplates post operatively.Thank you again for your feedback.This information allows choicespine to continue to improve during alpha launch of the product line.Choicespine will continue to monitor our feedback for repeated instances.Please let us know if we can provide any additional information or support for the continued use of the tigershark m system.
Event or Problem Description
The surgeon provided postoperative images of a tigershark m cage where the spacer moved posteriorly from its position during the original surgery.The dr.Is planning on revising the implant on (b)(6) 2024.The tsm implantation surgery occurred on (b)(6) 2024.The procedure was an l4/l5 tlif.The implants used were 32mm length, 6-degree endplates (s-pt50-e3206, 11590-02) and a 32mm x 4mm spacer (s-pt50-a3204, 10455-35).In the initial surgery, the dr.Attempted to insert a 5mm spacer (s-pt50-a3205, 10492-18).However, the expansion resistance caused the spacer inserter to disassociate from the insertion rails twice, preventing the successful mating of the endplates with the spacer.The 5mm spacer was backed out and the spacer inserter was removed from the insertion rails.He then requested a 4mm spacer.The 4mm spacer was attached to the spacer inserter and the spacer inserter, with the 4mm spacer, was attached to the insertion rails and advanced to expand the implant.The expansion and mating of the 4mm spacer with the endplates was successful without any observed issues.It was noted during the case that the cam locking step went as expected and it was felt at that time that the cam was locked.After pedicle screws were implanted, the dr.Reduced the spondylolisthesis at that level using the reduction threads inside the extended tabs of the pedicle screws.After this reduction, it was noticed, on fluoroscopic imaging, that the nose of the inferior tsm endplate was slightly anterior to the noses of the tsm spacer and the tsm superior endplate.It was decided that attempting to correct this misalignment could potentially do more damage than good and that the misalignment was minimal enough that the implant should hold its position postoperatively.

• Brand Name: CHOCIESPINE TIGERSHARK M MODULAR INTERBODY SYSTEM
• Common Device Name: TIGERSHARK M, STERILE, SPACER,32LX4H
• 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: 21106458
• Report Number: 3005819474-2024-00006
• Device Sequence Number: 8136570
• Product Code: MAX
• UDI-Device Identifier: 00840996188951
• UDI-Public: 00840996188951
• 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: 2024
• 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): 12/11/2024

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-A3204
• Device Lot Number: 10455-35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/08/2025
• 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: 63 YR
• Patient Sex: Male