Mariner 41-6550-1Recalls & reported problems
Seaspine Orthopedics Corporation · Solid Screw 6.50 x 50mm · Class 2 · Implant
All models of Mariner (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10889981068257), received between Dec 16, 2021 and Dec 16, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2021Fracture; Fracture
A PATIENT UNDERWENT A 1-LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINE SURGERY ON (B)(6) 2020 WHICH CONSISTED OF SEASPINE'S REEF TO INTERBODY AS WELL AS SEASPINE'S MARINER PEDICLE SCREW SYSTEM. A REVISION SURGERY OCCURRED ON (B)(6) 2021 DUE TO THREE MARINER SCREWS THAT FRACTURED IN THE POSTOPERATIVE PERIOD. THE SURGEON WAS ABLE TO SUCCESSFULLY REMOVE TWO OF THE SCREWS AND ONE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13018505 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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