Mariner Outrigger 99-1017-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889981173395), received between Apr 30, 2021 and Jan 5, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2022Material Deformation; Material Deformation

  DURING SURGERY TO ELONGATE RODS, ONE OF THE SET SCREWS ON THE LEFT SIDE CONNECTOR SHOWED EXCESSIVE RESISTANCE AND WAS UNABLE TO BE REMOVED. WHILE TRYING TO REMOVE THE SCREW, THE INITIAL SCREWDRIVER WAS DEFORMED. THE SURGEON THEN TRIED OTHER SCREWDRIVERS (FROM THE SYSTEM) BUT THE SCREW BEGAN TO DEFORM. OTHER UNIVERSAL EXTRACTION ATTEMPTS WERE UNSUCCESSFUL AND FINALLY THE SCREW WAS DEFORMED AND THEY COULDN'T LOOSEN IT, SO THEY HAD TO MAKE A LARGER INCISION, RELEASE THE ROD, REMOVE THE ROD AND IMPLANTED A NEW STRAIGHT ROD AND A NEW OUTRIGGER CONNECTOR.

  Patient problems: Failure of Implant

  MAUDE report 13171704 ↗
• MalfunctionApr 30, 2021Material Separation; Migration; Material Separation; Migration

  THE PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF THE SEASPINE MARINER OUTRIGGER SPINAL SYSTEM TO CONNECT SEASPINE'S MARINER AND DAYTONA SYSTEMS. THE SURGEON NOTED AN OUTRIGGER CONNECTOR ROD SLIP DURING A POSTOPERATIVE FOLLOW UP VISIT.

  Patient problems: Failure of Implant

  MAUDE report 11755052 ↗