MAUDE Adverse Event Report: CHOICESPINE, LLC CHOICESPINE TIGER SHARK SYSTEM; TIGER SHARK,STERILE,STR,9X32X11,6 DEG

Model Number	S-PT35-32116
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 11 mar dr.(b)(6) implanted a tigershark straight cage, however on the patient follow-up -complaint of pain- it was determined that the cage had migrated and retropulsed.Dr.(b)(6) put together a revision plan of either pushing the cage back in if the cage was thought to hold this time or to explant and put it in the largest cage he could get into the space.Revision on 27 march- ex-planted the old cage due to cage mobility and replaced it with a 14h cage.Dr.(b)(6) was struck with how poor the patient's bone was and largely held responsible for having to come back in and move/explant the original cage.Aside from this issue, there were no other delays, harm, or complaints associated with this ffr.This also led me to ask why a tigershark cage may migrate, and (b)(6) pointed out that over packing the cage could act as a counter to the roughened surface of tigershark.I spoke with (b)(6) to keep an eye out for this as a heads-up, but based on what i've been told, i don't believe this was the issue this time.
Additional Manufacturer Narrative
I wanted to provide a brief update regarding the recent incident involving the implant (s-pt35-32116, tiger shark, sterile, str, 9x32x11, 6 deg, 20231016x).Unfortunately, the implant was discarded in the operating room, and as a result, no parts were examined during the investigation process.However, feedback from the procedure highlighted concerns about bone quality being an issue, and there is also a possibility that over-packing the cage may have contributed to cage retropulsion.Regrettably, without access to the implant, we couldn't determine a definitive root cause.This is the first occurrence.Please continue to inform choice spine of issues concerning tigershark straight.This is the first occurrence for the tigershark straight, so we will continue to monitor feedback as it comes in.

• Brand Name: CHOICESPINE TIGER SHARK SYSTEM
• Common Device Name: TIGER SHARK,STERILE,STR,9X32X11,6 DEG
• 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 ; 8652433967
• MDR Report Key: 19201009
• Report Number: 3005819474-2024-00004
• Device Sequence Number: 8106769
• Product Code: MAX
• UDI-Device Identifier: 00840996173131
• UDI-Public: 00840996173131
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K172816
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• 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): 04/01/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: S-PT35-32116
• Device Lot Number: 20231016X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/29/2024
• 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: 50 YR
• Patient Sex: Female