Mariner 41-3010Recalls & reported problems
Seaspine Orthopedics Corporation · Polyaxial Head · Class 2
All models of Mariner (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981155117), received between May 8, 2026 and May 8, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Damaged Thread” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Reports received per month
Recalls naming this device
- May 28, 2026Open, Classified
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Z-2762-2026 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Damaged Thread1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Damaged Thread
ON 10 APR 2026 SEASPINE/ORTHOFIX WAS MADE AWARE OF A 30-MINUTE SURGICAL DELAY INVOLVING THE MARINER SPINAL SYSTEM. PER THE REPORTER, AFTER THE SURGEON IMPLANTED A SCREW DURING AN L3 PELVIS CASE ON (B)(6) 2026, HE EXPERIENCED ISSUES THREADING THE SET SCREW ONTO THE TULIP. THE SURGEON ATTEMPTED TO RESOLVE THE ISSUE USING TWO DIFFERENT SET SCREWS, HOWEVER, NEITHER SET SCREW WOULD THREAD ONTO THE TULIP. THE SURGEON PROCEEDED TO REMOVE THE SCREW AND TULIP AND REPLACED IT WITH A NEW ONE. THE CASE WAS ABLE TO BE COMPLETED SUCCESSFULLY AND NO PATIENT INJURIES WERE REPORTED. THE ISSUE RESULTED IN A DELAY OF APPROXIMATELY 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25129353 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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