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

Model Number 99-1017-12

Device Problems Material Separation (1562); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

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 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
• Type of Device: PARALLEL, CLOSED/SIDE-LOADING, 16MM
• 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: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 11755052
• MDR Text Key: 250244188
• Report Number: 3012120772-2021-00037
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981173395
• UDI-Public: 10889981173395
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99-1017-12
• Device Catalogue Number: 99-1017-12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1