MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER POINTLOCK SET SCREW

Model Number	MD1-100016
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A patient underwent an initial surgery on (b)(6) 2024 and was scheduled for a revision adjacent level surgery on (b)(6) 2024.While performing the revision surgery, the surgeon noticed that a mariner set screw had popped off post-operatively.Customer confirms there was no patient injury, no delay in surgery and the surgery was completed successfully.Although requested, the product is not available for evaluation.

• Brand Name: MARINER POINTLOCK SET SCREW
• Common Device Name: SCREW
• 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: 21093775
• Report Number: 3012120772-2025-00001
• Device Sequence Number: 21118520
• Product Code: NKB
• UDI-Device Identifier: 10889981283803
• UDI-Public: 10889981283803
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K232566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/07/2025

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: MD1-100016
• Device Catalogue Number: MD1-100016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/07/2025
• 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