MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION TRANSITION TI ROD, 4.0MM TO 6.0MM, 500MM

Model Number	PC1-524060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No returns were received.However, the report was confirmed via the provided x-ray image.The rod was fractured above the uppermost cervical screw construct.Root cause could not be determined.
Event or Problem Description
On (b)(6) 2024, a patient underwent spinal surgery utilizing seaspine's northstar oct posterior cervical fusion system.During a follow-up on (b)(6) 2024, a rod fracture was observed.Approximately a week later the occipital plate tulip was observed to have disassociated with the plate.Both devices remain implanted.It is unknown if a revision surgery is planned.No patient injury was reported.This report is for the pc1-524060 transition ti rod, 4.0mm to 6.0mm, 500mm.

• Brand Name: TRANSITION TI ROD, 4.0MM TO 6.0MM, 500MM
• Common Device Name: ROD
• 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: 20529992
• Report Number: 3012120772-2024-00101
• Device Sequence Number: 8284075
• Product Code: NKG
• UDI-Device Identifier: 10889981199043
• UDI-Public: 10889981199043
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K231654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/24/2024

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: PC1-524060
• Device Catalogue Number: PC1-524060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/24/2024
• 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: PC1-700003 EL CAPITAN OCC PLATE, SMALL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female