MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION NORTHSTAR OCT; POLY. SCREW, FAVORED ANGLE 4.5MM X 32MM

Model Number	PC1-104532
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pc1-104532 poly.Screw, favored angle 4.5mm x 32mm was not returned and therefore could not be evaluated.The customer did provide a photo which appears to confirm the reported malfunction.However, the root cause could not be determined.At this time as there is no evidence to suggest a manufacturing or design defect occurred.Review of labeling: possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: bending, disassembly, or fracture of implant and components postoperative fracture due to trauma, defects, or poor bone stock.
Event or Problem Description
On (b)(6) 2025 seaspine/orthofix became aware that a screw dissembled intra-operatively during a surgery utilizing the northstar oct spinal system.The surgeon was adjusting the height of the favored angle screw (pc1-104532) with a final driver, when the screw disassembled.The surgeon was making height adjustments to the screw when the washer dislodged.Per the reporter, all the pieces were retrieved.This led to a delay of approximately 30 minutes; prompting this report.The surgery was able to be completed successfully, and no patient injuries were reported.

• Brand Name: NORTHSTAR OCT
• Common Device Name: POLY. SCREW, FAVORED ANGLE 4.5MM X 32MM
• 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: robin quiusky ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 23646598
• Report Number: 3012120772-2025-00065
• Device Sequence Number: 4823255
• Product Code: NKG
• UDI-Device Identifier: 10889981197070
• UDI-Public: 10889981197070
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K193615
• 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
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PC1-104532
• Device Catalogue Number: PC1-104532
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/25/2025
• 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