MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION REEF TA; TA REMOVAL TOOL

Model Number	TA2-005002
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Dural Tear (1417)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a surgery that took place on (b)(6) 2025, the surgeon was attempting to insert a trial into the patient using the reef ta inserter and upon malleting the trial into the disc space, it unexpectedly dislodged and moved into the dura.The surgeon was able to retrieve the trial using curettes and other instruments, but the ta removal tool was not effective as it could not securely grip the back of the trial.After the dural tear, the surgeon attempted to load another trial, however, the surgeon was able to detach it by hand, indicating a potential issue with the locking mechanism.This issue caused a one hour delay while the surgeon had to repair the dura.Customer confirms the surgeon followed the appropriate surgical technique for locking the trial on the inserter and that the patient is doing well after the surgery.
Additional Manufacturer Narrative
H3: instrument has been returned, but outcome of the investigation is still pending.Review of labeling: intraoperative warnings: bending, disassembly, or fracture of implant and components.Dural leak requiring surgical repair.
Additional Manufacturer Narrative
Update to h3: device evaluated by manufacturer changed to "yes".Investigation conclusion: functional testing with the ta2-005002 removal tool and the trial indicated the instrument to be fully functional and able to attach to trial.Reported failure was unable to be confirmed.Root cause: the removal tool was found to be fully functional and able to grab trials.It is possible grabbing tip may not have been fully extended and therefore not able to expand to grab trial, or final position of trial may not have been aligned with surgical area to allow removal tool to securely grab feature.

• Brand Name: REEF TA
• Common Device Name: TA REMOVAL TOOL
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: danielle nelson-archer ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 21702148
• Report Number: 3012120772-2025-00018
• Device Sequence Number: 21365000
• Product Code: LXH
• UDI-Device Identifier: 10889981318406
• UDI-Public: 10889981318406
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K241466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: TA2-005002
• Device Catalogue Number: TA2-005002
• Device Lot Number: WT36751A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown