Mariner Deformity MD1-115535Recalls & reported problems
Seaspine Orthopedics Corporation · Uni-Planar Screw, 5.5mm X 35mm · 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 10889981235758), received between Jun 24, 2026 and Jun 24, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
MalfunctionJun 24, 2026Detachment of Device or Device Component
ON 29 MAY 2026, ORTHOFIX BECAME AWARE OF AN EVENT INVOLVING A SURGICAL PROCEDURE UTILIZING THE MARINER DEFORMITY SYSTEM. IT WAS REPORTED THAT AN MD1-115535 UNI-PLANAR SCREW, 5.5MM X 35MM DISASSEMBLED INTRA-OPERATIVELY. THE SCREW AND ITS COMPONENTS WERE RETRIEVED FROM THE SURGICAL SITE, HOWEVER, ACCORDING TO THE REPORTER THIS RESULTED IN A SURGICAL DELAY OF 30 MINUTES. NO PATIENT INJURY, DEATH, OR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25615769 ↗
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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