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	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a revision surgery on (b)(6) 2025, the surgeon was removing a broken 99-1022-300 mariner outrigger rod connector (an integrated rod and connector component), when one of the associated 99-1000-01 set screw components split in half.The bottom half of the set screw could not be removed, so the broken rod connector was left in the patient.The event did not lead to a clinically relevant increase in the duration of the surgical procedure and the revision surgery was completed successfully with side-to-side connectors and a new rod.Customer confirms there was no patient injury.Mdr report #3012120772-2025-00015 documented for the broken rod that initially required the revision surgery.This mdr is to document the broken set screw left inside the patient.
Additional Manufacturer Narrative
H3: set screws from the connector have been returned, but outcome of the investigation is still pending.Review of labeling: intraoperative warnings.Bending, disassembly, or fracture of implant and components.
Additional Manufacturer Narrative
Update to h3: device evaluated by manufacturer changed to "yes." investigation conclusion: the set screw (99-1000-01) components of the closed, axial rod, long, 300mm (99-1022-300) were visually inspected and the reported failure mode was confirmed.Upon closer investigation of the hexalobe, the clockwise walls of each lobe were noticeably deformed, which indicates excessive torque during the implant's initial insertion.The set screw sheared during application of torque during removal.There was a brittle fracture that followed the path of the first thread on the set screw.There was also significant wear observed on the threads via removal of the anodized surface treatment, indicating significant torque during either insertion or removal operations.The implants were dimensionally inspected and all critical features relevant to the failure mode were found to be within specification.An additional closed, axial rod, long, 300mm (99-1022-300) was pulled from inventory.The set screw (99-1000-01) components were visually and dimensionally inspected and all critical features relevant to the failure mode were found to be within specification.Root cause: the critical features relevant to the failure mode were found to be within specification.The root cause of this failure was determined to be excessive force during insertion that plastically deformed the set screw and weakened areas with thin wall conditions.

• 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: 21758357
• Report Number: 3012120772-2025-00014
• Device Sequence Number: 13198811
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: 99-1022-300
• Device Catalogue Number: 99-1022-300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/30/2025
• 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: Other
• Patient Sex: Unknown