MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION POLY. SCREW, 4.0MM X 18MM

Model Number	PC1-004018
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The screw was returned and evaluated by product engineering.Visual inspection confirmed the screw broke at the neck where the screw head transitions into the shank.The cut of the break is flat and clean, consistent with the screw being subject to excessive torque.Review of labeling: possible adverse events bending, disassembly, or fracture of implant and components.
Event or Problem Description
On (b)(6) 2024, a patient underwent spinal surgery utilizing seaspine's northstar oct posterior cervical fusion system.When trying to remove a screw, it broke at the neck.The screw shank was left implanted.No patient injury was reported.

• Brand Name: POLY. SCREW, 4.0MM X 18MM
• 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: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 20164162
• Report Number: 3012120772-2024-00065
• Device Sequence Number: 7291821
• Product Code: NKG
• UDI-Device Identifier: 10889981196196
• UDI-Public: 10889981196196
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K231654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 09/06/2024

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: PC1-004018
• Device Catalogue Number: PC1-004018
• Device Lot Number: CR52481C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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