MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER MIS; MIS PRECONTOURED ROD, 5.5 X 140MM

Model Number	MM1-155140
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision surgery was performed on (b)(6) 2025 to replace the two firebird nxg set screws and the mariner mis rod with an approved orthofix straight rod (pn 53-2160).The explanted components were not made available for analysis as they were discarded during the revision surgery.Additionally, no lot information was provided.Three torque handles (pn 36-1512) were returned for evaluation and one was found slightly under specification; however, it is unknown which handle was used during the intial surgery.Based on the available information, the most likely cause of the construct failure is the use of an incompatible, off-label construct.Insufficient torque may have further contributed to the issue.Review of labeling: possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis).Bending, disassembly, or fracture of implant and components.Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration, or pain pain, discomfort, or abnormal sensations due to the presence of the device pressure on skin where inadequate tissue coverage exists over the implant, with potential extrusion through the skin.Dural leak requiring surgical repair.Cessation of growth of the fused portion of the spine.Subsidence of the implant into adjacent bone.Loss of proper spinal curvature, correction, height, and/or reduction.Increased biomechanical stress on adjacent levels.Improper surgical placement of the implant causing stress shielding of the graft or fusion mass.Intraoperative fracture or perforation of the spine.Postoperative fracture due to trauma, defects, or poor bone stock.Serious complications associated with any surgery may occur.These include, but are not limited to: wound complications, infection, genitourinary, gastrointestinal disorders, respiratory disorders; cardiovascular disorders, including myocardial infarction (heart attack) or arrythmias; neurologic injuries resulting in weakness, paralysis, numbness, tingling, or pain; vascular (blood vessel) injuries, including hemorrhage (bleeding); thrombosis (blood clots) leading to deep venous thrombosis or pulmonary embolism; or death.
Event or Problem Description
On 17 apr 2025, it was reported that a mariner mis rod was used off-label in conjunction with firebird nxg / janus screws and set screws.The original surgery took place on (b)(6) 2024.During routine follow up, it was discovered that the firebird nxg set screws separated from the construct in the postoperative period.As a result, a revision surgery occurred on (b)(6) 2025 to remove two firebird nxg set screws and the mariner mis rod.

• Brand Name: MARINER MIS
• Common Device Name: MIS PRECONTOURED ROD, 5.5 X 140MM
• 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
• MDR Report Key: 21934073
• Report Number: 3012120772-2025-00027
• Device Sequence Number: 7893526
• Product Code: NKB
• UDI-Device Identifier: 10889981217600
• UDI-Public: 10889981217600
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 04/30/2025

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: MM1-155140
• Device Catalogue Number: MM1-155140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 04/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 36-2001 FIREBIRD NXG SET SCREW.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male