MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER PEDICLE SCREW SYSTEM; SOLID SCREW 8.50 X 90MM

Model Number	41-8590-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a mariner screw (41-8590-1) that fractured intra-operatively.This implant failure happened when the surgeon was adjusting the height of his 8.5x90mm s2/ai screw.The shank was left in the patient.
Additional Manufacturer Narrative
The reported fracture was confirmed during inspection of the returned device however, the cause of the fracture was not identified.No other information regarding the reported event were provided by the customer other than the shank remained in the patient.There was no mention of any remedial actions or any adverse effects experienced by the patient, if any.Possible adverse events: bending, disassembly or fracture of implant and components.
Event or Problem Description
Supplemental report filed to include lot and udi numbers, corrected 510k number, and added device manufacturer date.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Common Device Name: SOLID SCREW 8.50 X 90MM
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008 ; 7607278399
• MDR Report Key: 16072039
• Report Number: 3012120772-2022-00058
• Device Sequence Number: 6187143
• Product Code: NKB
• UDI-Device Identifier: 10889981069568
• UDI-Public: 10889981069568
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 41-8590-1
• Device Catalogue Number: 41-8590-1
• Device Lot Number: AW158503D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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