MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER OUTRIGGER REVISION SYSTEM; PARALLEL, CLOSED/SIDE-LOADING, 16MM

Model Number	99-1017-12
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No explants were made available for analysis and no x-rays or additional details regarding the surgical technique or patient's condition or treatment plan have been communicated to seaspine.Review of labeling: possible adverse events bending, disassembly or fracture of implant and components loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.
Event or Problem Description
The patient underwent spinal surgery consisting of the seaspine mariner outrigger spinal system to connect seaspine's mariner and daytona systems.The surgeon noted an outrigger connector rod slip during a postoperative follow up visit.

• Brand Name: MARINER OUTRIGGER REVISION SYSTEM
• Common Device Name: PARALLEL, CLOSED/SIDE-LOADING, 16MM
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• MDR Report Key: 11755052
• Report Number: 3012120772-2021-00037
• Device Sequence Number: 19875853
• Product Code: NKB
• UDI-Device Identifier: 10889981173395
• UDI-Public: 10889981173395
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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: 99-1017-12
• Device Catalogue Number: 99-1017-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1