Mariner Deformity MD1-136550Recalls & reported problems
Seaspine Orthopedics Corporation · M/L Uni-Planar Screw, Extended Tab, 6.5mm X 50mm · Class 2 · Implant
All models of Mariner Deformity (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981292843), received between Apr 14, 2026 and Apr 14, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Damaged Thread” (1 report).
1 other recall cover devices cleared under the same FDA submission (K211606); they may or may not involve this specific model.
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
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.
MalfunctionApr 14, 2026Damaged Thread
ON 23 MAR 2026 SEASPINE/ORTHOFIX WAS MADE AWARE OF A 45-MINUTE SURGICAL DELAY INVOLVING THE MARINER DEFORMITY SPINAL SYSTEM. PER THE REPORTER, THE SURGEON HAD TROUBLE SEATING THE FINAL LEFT L4 SET SCREW INTO A UNIPLANAR EXTENDED TAB SCREW. ADDITIONALLY, THE REDUCERS COULD NOT REDUCE THE ROD FULLY AND DISCONNECTED FROM THE TULIP. ULTIMATELY THE SCREW AND SET SCREW WERE REMOVED AND REPLACED AND THE CASE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR THE ASSOCIATED SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24879226 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K211606. One submission often covers many models, so check the product and lot details in each record.
- Z-3226-2026 · Aug 19, 2026 · Open, ClassifiedSeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
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
- 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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