Mariner MIS MM1-155140Recalls & reported problems
Seaspine Orthopedics Corporation · MIS PRECONTOURED ROD, 5.5 x 140MM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981217600), received between Apr 30, 2025 and Apr 30, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2025Device-Device Incompatibility; Device-Device Incompatibility
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.
Patient problems: Failure of Implant
MAUDE report 21934073 ↗
Other Thoracolumbosacral pedicle screw system devices
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- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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