Mariner DeformityRecalls & reported problems across all models

We found 3 models of Mariner Deformity by Seaspine Orthopedics Corporation in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Apr 14, 2026 and Jun 24, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Damaged Thread” (1 report).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Mariner Deformity recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 19, 2026Class IIOpen, Classified

   The proximal thread depth of the spinal device is out of design specification.

   Z-3226-2026 · Root cause: Process design · Recall details · FDA record ↗

Most reported Mariner Deformity problems

Mariner Deformity models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Mariner Deformity MD1-300010-12

  Appliance, fixation, spinal intervertebral body
  1 recall0 reports
• Mariner Deformity MD1-115535

  Thoracolumbosacral pedicle screw system
  1 report
• Mariner Deformity MD1-136550

  Thoracolumbosacral pedicle screw system
  1 report

Recent Mariner Deformity adverse event reports

The 2 most recent reports across all models, 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 ↗
• 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 ↗

Other Seaspine Orthopedics Corporation products

• Mariner15 models · 147 reports · 1 recall
• Daytona Small Stature3 models · 14 reports · 2 recalls
• Fathom3 models · 2 reports · 2 recalls
• NorthStar24 models · 15 reports · 1 recall
• Meridian8 models · 8 reports · 1 recall
• Mariner RDX6 models · 0 reports · 1 recall
• Virata25 models · 0 reports · 1 recall
• Reef TA2 models · 0 reports · 1 recall