Mariner Outrigger 99-1022-300Recalls & reported problems

Seaspine Orthopedics Corporation · Closed, Axial Rod, Long, 300mm · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889981173708), received between Apr 2, 2025 and Apr 2, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

InjuryApr 2, 2025Fracture; Fracture
THE SURGEON OBSERVED VIA X-RAY ON (B)(6) 2025, THAT THE RODS OF THE 99-1022-300 MARINER OUTRIGGER ROD CONNECTOR (AN INTEGRATED ROD AND CONNECTOR COMPONENT IMPLANTED DURING AN INITIAL SURGERY (B)(6) 2024) HAD FRACTURED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. WHILE PERFORMING THE REVISION SURGERY, ONE OF THE SET SCREWS FRACTURED, SO THE BROKEN ROD CONNECTOR WAS UNABLE TO BE REMOVED, HOWEVER, THE SURGERY WAS COMPLETED SUCCESSFULLY WITH SIDE-TO-SIDE CONNECTORS AND A NEW ROD. CUSTOMER CONFIRMS THERE WAS NO PATIENT INJURY. THE BROKEN RODS ARE NOT AVAILABLE FOR EVALUATION. MDR REPORT #3012120772-2025-00014 DOCUMENTED FOR THE A BROKEN SET SCREW THAT WAS LEFT INSIDE THE PATIENT DURING THE REVISION SURGERY. THIS MDR IS TO DOCUMENT THE BROKEN RODS THAT LED TO THE REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21758372 ↗
MalfunctionApr 2, 2025Fracture; Fracture
DURING A REVISION SURGERY ON (B)(6) 2025, THE SURGEON WAS REMOVING A BROKEN 99-1022-300 MARINER OUTRIGGER ROD CONNECTOR (AN INTEGRATED ROD AND CONNECTOR COMPONENT), WHEN ONE OF THE ASSOCIATED 99-1000-01 SET SCREW COMPONENTS SPLIT IN HALF. THE BOTTOM HALF OF THE SET SCREW COULD NOT BE REMOVED, SO THE BROKEN ROD CONNECTOR WAS LEFT IN THE PATIENT. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH SIDE-TO-SIDE CONNECTORS AND A NEW ROD. CUSTOMER CONFIRMS THERE WAS NO PATIENT INJURY. MDR REPORT #3012120772-2025-00015 DOCUMENTED FOR THE BROKEN ROD THAT INITIALLY REQUIRED THE REVISION SURGERY. THIS MDR IS TO DOCUMENT THE BROKEN SET SCREW LEFT INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21758357 ↗

Device details

UDI-DI	`10889981173708`
Brand	Mariner Outrigger
Model	99-1022-300
Company	Seaspine Orthopedics Corporation
Product code	NKB · Thoracolumbosacral pedicle screw system
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 3, 2026

Device type (GMDN): Bone-screw internal spinal fixation system rod

An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Other Thoracolumbosacral pedicle screw system devices

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All Thoracolumbosacral pedicle screw system devices →

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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