Mariner MD2-004105Recalls & reported problems
Seaspine Orthopedics Corporation · Torque Limiting Adapter, 105in-lbs · Class 1
All models of Mariner (15)
Data updated Oct 18, 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 10889981272654), received between Nov 25, 2025 and Nov 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Damaged Thread” (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
- 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.
MalfunctionNov 25, 2025Damaged Thread; Damaged Thread
SEASPINE/ORTHOFIX BECAME AWARE ON 28-OCT-2025 THAT DURING FINAL TIGHTENING OF THE CONSTRUCT, THE SURGEON REPORTED DIFFICULTY ACHIEVING FINAL TORQUE ON THE LEFT S1 SET SCREW. AFTER SUCCESSFULLY TIGHTENING THE RIGHT S1 SCREW, THE SURGEON ATTEMPTED TO FINAL TIGHTEN THE LEFT S1 SET SCREW; HOWEVER, THE SET SCREW REPEATEDLY "POPPED" AND CONTINUED TO TURN WITHOUT THE TORQUE HANDLE CLICKING. THE SURGEON REMOVED THE ROD, REPLACED THE S1 SCREW ON THE LEFT SIDE, REINSERTED THE ROD, AND USED A NEW SET SCREW TO COMPLETE THE CONSTRUCT. THIS RESULTED IN AN ESTIMATED SURGICAL DELAY OF APPROXIMATELY 20-30 MINUTES, PROMPTING THIS REPORT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT INJURY OCCURRED. THIS REPORT IS BEING SUBMITTED FOR THE MD2-004105 TORQUE LIMITING ADAPTER, 105IN-LBS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23646597 ↗
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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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