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Mariner 41-7540-1Recalls & reported problems

Seaspine Orthopedics Corporation · Solid Screw 7.50 x 40mm · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981068950), received between Sep 3, 2020 and Sep 3, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Mechanical Problem1

Patient problems

  • Patient Problem/Medical Problem1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 3, 2020Mechanical Problem; Mechanical Problem

    THE PATIENT UNDERWENT SPINAL SURGERY ON (B)(6) 2020 CONSISTING OF SEASPINE'S MARINER PEDICLE SCREW SYSTEM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO CORRECT THE TRAJECTORY OF AN S1 SCREW (MFG REF (B)(4): 41-7540-1) THAT WAS REPORTED TO HAVE BEEN TOO LATERAL. DURING THE REVISION SURGERY, IT WAS DISCOVERED THAT THE SET SCREWS AT S1/S2 WERE LOOSE (MFG REF (B)(4): 41-1010). THE SURGEON COMPLETED THE REVISION SURGERY BY REPLACING AND REDIRECTING THE S1 SCREW AS PLANNED, REINSERTING THE SET SCREW, AND TIGHTENING THE REMAINING SET SCREWS.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 10491218 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.