MAUDE Adverse Event Report: SEASPINE, INC MARINER PEDICLE SCREW SYSTEM

Model Number	41-7550-2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
Seaspine was made aware on (b)(6) 2022 of an intraoperative screw fracture consisting of seaspine's mariner pedicle screw system.It was reported that while attempting to remove the suspect screw, the neck of the screw fractured.The surgeon was unable to remove the screw; therefore, the fractured screw remains in-situ.
Additional Manufacturer Narrative
The fractured screw remains inside the patient.No injury or medical intervention has been reported.The surgeon will continue to monitor the patient for any indication requiring intervention.Possible adverse events: bending, disassembly or fracture of implant and components.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• 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: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 15440096
• Report Number: 3013130772-2022-00029
• Device Sequence Number: 5581765
• Product Code: NKB
• UDI-Device Identifier: 10889981069001
• UDI-Public: 10889981069001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191648
• 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): 09/16/2022

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: 41-7550-2
• Device Catalogue Number: 41-7550-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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