MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER OUTRIGGER; CLOSED, AXIAL ROD, LONG, 300MM

Model Number	99-1022-300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is not available for evaluation; no lot information was provided.No definitive root cause could be established.Review of labeling: intraoperative warnings bending, disassembly, or fracture of implant and components.
Event or Problem Description
The surgeon observed via x-ray on (b)(6) 2025, that the rods of the 99-1022-300 mariner outrigger rod connector (an integrated rod and connector component implanted during an initial surgery (b)(6) 2024) had fractured.Revision surgery was performed on (b)(6) 2025.While performing the revision surgery, one of the set screws fractured, so the broken rod connector was unable to be removed, however, the surgery was completed successfully with side-to-side connectors and a new rod.Customer confirms there was no patient injury.The broken rods are not available for evaluation.Mdr report #3012120772-2025-00014 documented for the a broken set screw that was left inside the patient during the revision surgery.This mdr is to document the broken rods that led to the revision surgery.

• Brand Name: MARINER OUTRIGGER
• Common Device Name: CLOSED, AXIAL ROD, LONG, 300MM
• 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: 21758372
• Report Number: 3012120772-2025-00015
• Device Sequence Number: 18597314
• Product Code: NKB
• UDI-Device Identifier: 10889981173708
• UDI-Public: 10889981173708
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K183639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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: 99-1022-300
• Device Catalogue Number: 99-1022-300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2025
• Initial Report FDA Received Date: 04/02/2025
• 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: Other; Required Intervention
• Patient Sex: Unknown