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

Model Number	PC1-700000
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a surgery that took place on (b)(6) 2025, a piece of the northstar occipital plate broke off and became lodged in the northstar occipital plate bending wrench.The distributor rep reported that all of the fractured pieces were retrieved, however, the occipital plate was implanted without a portion of the plate.As the surgery was completed without a portion of the plate, orthofix/seaspine cannot guarantee the stability of the construct post-operatively; therefore, based on this risk characterization, the event was determined to be reportable.No patient injuries were reported.
Additional Manufacturer Narrative
H3: although the pc1-700000 el capitan occ plate, extra small was implanted, the distributor rep was able to return the pc2-310002 occ plate bending wrench and the portion of the pc1-700000 plate that had broken off.Investigation is pending.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.Intraoperative warnings: implants and components should not be bent, reshaped, contoured, or otherwise modified.Use great care to ensure that the implant surfaces are not scratched or notched, which may reduce the functional strength of the construct.
Additional Manufacturer Narrative
Investigation conclusion: the pc2-310002 occ plate bending wrench was returned and evaluated by product engineering.The returned occipital wrench was visually inspected to confirm the failure mode outlined in the complaint description.After reviewing the instrument, it was verified that the cranial side tab of the occipital plate was stuck inside of the cavity that is intended to bend that particular tab.Root cause: in the design of the pc2-310002 occ plate bending wrench, there are lip features on all slots of the instruments that allow for the mating plate relief feature to slide over prior to bending.During the visual review of the returned instrument, it was observed that the plate relief feature flipped in the wrong direction away from the lip feature.This means that the plate was loaded incorrectly to the bending wrench before the surgeon completed the bending step.By loading the cranial tab in this manner, it created the incorrect loading state onto the plate surface and caused the fracture when bending moment was applied.Therefore, the root cause of the failure mode can be attributed to user error by not loading the plate in the proper orientation.

• Brand Name: NORTHSTAR
• Common Device Name: EL CAPITAN OCC PLATE, EXTRA 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: danielle nelson-archer ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 24158108
• Report Number: 3012120772-2026-00001
• Device Sequence Number: 9029278
• Product Code: KWP
• UDI-Device Identifier: 10889981309633
• UDI-Public: 10889981309633
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: PC1-700000
• Device Catalogue Number: PC1-700000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/20/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PC2-310002.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown