Mariner Outrigger 99-1023-12Recalls & reported problems
Seaspine Orthopedics Corporation · Parallel, Side-Loading/Closed, Variable 8mm · Class 2 · Implant
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 10889981184940), received between Sep 3, 2021 and Sep 3, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Connection Problem1
- Loose or Intermittent Connection1
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.
MalfunctionSep 3, 2021Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem
ON (B)(6) 2021, A PROCEDURE WAS PERFORMED, AT WHICH TIME THE REFERENCED PRODUCTS WERE IMPLANTED FOR SPINAL DEFORMITY FROM T10 TO THE ILIAC SPINE LEVEL. DURING A REVISION SURGERY ON (B)(6) 2021, THE SURGEON OBSERVED A PROXIMAL FRACTURE ABOVE T10, SO THE SURGEON EXTENDED THE SURGERY TO T3 USING THE CONNECTORS BETWEEN THE PREVIOUS SURGERY AND THE NEW SURGERY. ALSO OBSERVED AT THE TIME WAS WHAT THE SURGEON REFERRED TO AS "ABUNDANT METALLOSIS". THERE HAS BEEN NO SUPPORTING EVIDENCE PROVIDED FOR THE FINDING OF METALLOSIS (PHYSIOLOGIC RESPONSE TO IMPLANT SECONDARY TO WEAR DEBRIS OR MEASURED SERUM METAL ION LEVELS). FOLLOW-UP WITH THE CUSTOMER REPRESENTATIVE DESCRIBES THE ALLEGATION OF METALLOSIS MAY HAVE BEEN AN INACCURATE DESCRIPTION OF WHAT WAS OBSERVED, AND THE SURGEON MAY HAVE BEEN REFERRING TO THE PRESENCE OF WITNESS MARKS (ORIGIN UNCONFIRMED) ON THE CONNECTORS. ADDITIONALLY, THE SIDE CONNECTOR ON ONE SIDE WAS FOUND 'OUT' AND THE CONNECTOR ON THE CONTRALATERAL SIDE WAS OBSERVED TO BE LOOSE. THE SPINE LEVELS COVERED WERE T10-T3, AND THE SPINE LEVELS AFFECTED WERE T10 AND ABOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12426102 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
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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