MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION NORTHSTAR OCT SYSTEM; EL CAPITAN OCC PLATE, SMALL

Model Number	PC1-700003
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intraoperative and postoperative imaging were reviewed.The index surgery imaging showed the occipital plate and screws intact and properly positioned.Follow-up imaging demonstrated construct separation at the occipital plate, with both tulip components appearing to have disassembled from the plate body.The occipital screws remained intact and fixed in the occiput.The device has not been returned for evaluation, and revision surgery details have not been provided.A definitive root cause cannot be determined at this time.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 posterior cervical fusion spine surgery on (b)(6) 2025 utilizing seaspine/orthofix's northstar occipital system.At a routine follow-up visit on (b)(6) 2025, radiographs demonstrated construct separation at the occipital plate.No intraoperative complications were reported.

• Brand Name: NORTHSTAR OCT SYSTEM
• Common Device Name: EL CAPITAN OCC PLATE, SMALL
• 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: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 22754744
• Report Number: 3012120772-2025-00044
• Device Sequence Number: 8599003
• Product Code: NKG
• UDI-Device Identifier: 10889981309640
• UDI-Public: 10889981309640
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K231654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 08/08/2025

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: PC1-700003
• Device Catalogue Number: PC1-700003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PC1-023540 PARALLEL, TOP LOADING; PC1-400000 NORTHSTAR OCT SET SCREW; PC1-504177 CONTOURED TI OCC ROD, 4.0MM X 170MM X 7; PC1-714010 OCC SCREW, 4.0MM X 10; PC1-714012 OCC SCREW, 4.0MM X 12
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown