MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER MIS; MIS POLYAXIAL HEAD

Model Number	MM1-000020
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports that during a surgery that took place around (b)(6) 2025 (exact date of surgery not provided), the surgeon noted on the final x-ray that the tulip on the mariner mis polyaxial head disassociated from the shank of the mariner 6.50 x 45mm cannulated screw.The surgeon chose to leave the construct as-is as the patient was already closed up.There was no delay in surgery and no patient injury reported.The surgeon does not plan to perform revision surgery at this time.Although three follow-up attempts were performed, no additional information was provided regarding this event.The product is not available for evaluation.
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: possible adverse events bending, disassembly, or fracture of implant and components.Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration, or pain.

• Brand Name: MARINER MIS
• Common Device Name: MIS POLYAXIAL HEAD
• 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: 21434816
• Report Number: 3012120772-2025-00008
• Device Sequence Number: 17275200
• Product Code: NKB
• UDI-Device Identifier: 10889981177805
• UDI-Public: 10889981177805
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191648
• 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): 02/21/2025

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: MM1-000020
• Device Catalogue Number: MM1-000020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/21/2025
• 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
• Patient Sex: Unknown