MAUDE Adverse Event Report: SEASPINE, INC MARINER MIS CANNULATED SCREW

Model Number	41-6545-2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation as the screw remains implanted.The customer reported that the patient was asymptomatic.No revision surgery is planned.Possible adverse events: bending, disassembly, or fracture of implant and components.
Event or Problem Description
On (b)(6) 2023, a patient underwent spinal surgery consisting of the mariner mis posterior fixation system.Seaspine was made aware on 9 feb 2024 that a 41-6545-2 cannulated screw 6.50 x 45mm had fractured at the neck at s1.The patient is asymptomatic, and no revision surgery is planned.

• Brand Name: MARINER MIS CANNULATED SCREW
• Common Device Name: SCREW
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 18839051
• Report Number: 3012120772-2024-00004
• Device Sequence Number: 18025764
• Product Code: NKB
• UDI-Device Identifier: 10889981068240
• UDI-Public: 10889981068240
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K191648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/05/2024

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: 41-6545-2
• Device Catalogue Number: 41-6545-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 03/05/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Female