MarinerRecalls & reported problems across all models
Seaspine Orthopedics Corporation · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Mariner model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 147
- Deaths reported
- 1
- Injuries reported
- 31
- Recalls
- 1
We found 15 models of Mariner by Seaspine Orthopedics Corporation in the FDA's device registry (GUDID). Together they are named in 147 adverse event reports in the FDA's MAUDE database, received between Jul 20, 2017 and May 8, 2026 — classified as 1 death, 31 injuries, 115 malfunctions.
The most frequently reported specific device problem is “Migration” (47 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Mariner recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 28, 2026Class IIOpen, Classified
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Z-2762-2026 · Root cause: Process change control · Recall details · FDA record ↗
Most reported Mariner problems
Device problems
- Migration47
- Detachment of Device or Device Component41
- Mechanical Problem23
- Premature Separation20
- Separation Problem16
- Fracture7
- Damaged Thread5
- Loosening of Implant Not Related to Bone-Ingrowth4
Patient problems
- Failure of Implant100
- Insufficient Information22
- Patient Problem/Medical Problem22
- No Clinical Signs, Symptoms or Conditions16
- Pain6
- Foreign Body In Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Death1
Mariner models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Mariner 41-1010Thoracolumbosacral pedicle screw system1 death85 reports
- Mariner 41-3010Thoracolumbosacral pedicle screw system1 recall1 report
- Mariner 41-1000ORTHOSIS, SPINAL PEDICLE FIXATION25 reports
- Mariner MD1-100016Appliance, fixation, spinal intervertebral body25 reports
- Mariner 41-3000ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Mariner 41-6540-1ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Mariner 41-6545-2Orthosis, spondylolisthesis spinal fixation1 report
- Mariner 41-6550-1Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Mariner 41-7540-1Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Mariner 41-7545-1ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Mariner 41-7550-2ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Mariner 41-7555-2Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Mariner 41-8545-1Orthosis, spondylolisthesis spinal fixation1 report
- Mariner 41-8590-1Orthosis, spondylolisthesis spinal fixation1 report
- Mariner MD2-004105ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent Mariner adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Damaged Thread
ON 10 APR 2026 SEASPINE/ORTHOFIX WAS MADE AWARE OF A 30-MINUTE SURGICAL DELAY INVOLVING THE MARINER SPINAL SYSTEM. PER THE REPORTER, AFTER THE SURGEON IMPLANTED A SCREW DURING AN L3 PELVIS CASE ON (B)(6) 2026, HE EXPERIENCED ISSUES THREADING THE SET SCREW ONTO THE TULIP. THE SURGEON ATTEMPTED TO RESOLVE THE ISSUE USING TWO DIFFERENT SET SCREWS, HOWEVER, NEITHER SET SCREW WOULD THREAD ONTO THE TULIP. THE SURGEON PROCEEDED TO REMOVE THE SCREW AND TULIP AND REPLACED IT WITH A NEW ONE. THE CASE WAS ABLE TO BE COMPLETED SUCCESSFULLY AND NO PATIENT INJURIES WERE REPORTED. THE ISSUE RESULTED IN A DELAY OF APPROXIMATELY 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25129353 ↗MalfunctionApr 14, 2026Damaged Thread
ON 23 MAR 2026, SEASPINE/ORTHOFIX WAS MADE AWARE OF A 45-MINUTE SURGICAL DELAY INVOLVING THE MARINER DEFORMITY SPINAL SYSTEM. PER THE REPORTER, THE SURGEON HAD TROUBLE SEATING THE FINAL LEFT L4 SET SCREW INTO A UNIPLANAR EXTENDED TAB SCREW. ADDITIONALLY, THE REDUCERS COULD NOT REDUCE THE ROD FULLY AND DISCONNECTED FROM THE TULIP. ULTIMATELY THE SCREW AND SET SCREW WERE REMOVED AND REPLACED AND THE CASE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR THE ASSOCIATED SET SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24879228 ↗InjuryJan 2, 2026Migration
ON 08 DEC 2025, SEASPINE/ORTHOFIX WAS MADE AWARE OF A POST-OPERATIVE SCREW FRACTURE RELATED TO THE MARINER MIS POSTERIOR FIXATION SPINAL SYSTEM. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO CORRECT THE SCREW FRACTURE. NEITHER THE INDEX SURGERY DATE NOR THE REVISION SURGERY DATE FOR THE SCREW FRACTURE WERE PROVIDED. (SEE MDR 3012120772-2025-00071 FOR THIS EVENT). AFTER THE REVISION SURGERY, IT WAS REPORTED THAT A POINTLOCK SET SCREW BACKED OUT/LOOSENED POST-OPERATIVELY, WHICH REQUIRED AN ADDITIONAL REVISION SURGERY. THIS REPORT IS 1 OF 2 BEING FILED TO DOCUMENT THE POST-OPERATIVE SET SCREW BACK OUT /LOOSENING. SEE MDR 3012120772-2025-00073 FOR THE SECOND REPORT RELATED TO THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23945705 ↗InjuryJan 2, 2026Migration
ON 08 DEC 2025, SEASPINE/ORTHOFIX WAS MADE AWARE OF A POST-OPERATIVE SCREW FRACTURE RELATED TO THE MARINER MIS POSTERIOR FIXATION SPINAL SYSTEM. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO CORRECT THE SCREW FRACTURE. NEITHER THE INDEX SURGERY DATE NOR THE REVISION SURGERY DATE FOR THE SCREW FRACTURE WERE PROVIDED. (SEE MDR 3012120772-2025-00071 FOR THIS EVENT). AFTER THE REVISION SURGERY, IT WAS REPORTED THAT A POINTLOCK SET SCREW BACKED OUT/LOOSENED POST-OPERATIVELY, WHICH REQUIRED AN ADDITIONAL REVISION SURGERY. THIS REPORT IS 2 OF 2 BEING FILED TO DOCUMENT THE POST-OPERATIVE SET SCREW BACK OUT /LOOSENING. SEE MDR 3012120772-2025-00071 FOR THE FIRST REPORT RELATED TO THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23945701 ↗MalfunctionNov 25, 2025Damaged Thread; Damaged Thread
SEASPINE/ORTHOFIX BECAME AWARE ON 28-OCT-2025 THAT DURING FINAL TIGHTENING OF THE CONSTRUCT, THE SURGEON REPORTED DIFFICULTY ACHIEVING FINAL TORQUE ON THE LEFT S1 SET SCREW. AFTER SUCCESSFULLY TIGHTENING THE RIGHT S1 SCREW, THE SURGEON ATTEMPTED TO FINAL TIGHTEN THE LEFT S1 SET SCREW; HOWEVER, THE SET SCREW REPEATEDLY "POPPED" AND CONTINUED TO TURN WITHOUT THE TORQUE HANDLE CLICKING. THE SURGEON REMOVED THE ROD, REPLACED THE S1 SCREW ON THE LEFT SIDE, REINSERTED THE ROD, AND USED A NEW SET SCREW TO COMPLETE THE CONSTRUCT. THIS RESULTED IN AN ESTIMATED SURGICAL DELAY OF APPROXIMATELY 20-30 MINUTES, PROMPTING THIS REPORT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT INJURY OCCURRED. THIS REPORT IS BEING SUBMITTED FOR THE MD2-004105 TORQUE LIMITING ADAPTER, 105IN-LBS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23646597 ↗MalfunctionNov 3, 2025Difficult or Delayed Positioning; Damaged Thread; Difficult or Delayed Positioning; Damaged Thread
A PATIENT UNDERWENT SPINAL SURGERY ON (B)(6) 2025 CONSISTING OF ORTHOFIX/SEASPINE'S MARINER PEDICLE SCREW SYSTEM. IT WAS REPORTED ON (B)(6) 2025, THAT THE THREADS OF A MD1-100016 POINTLOCK SET SCREW FRACTURED DURING FINAL TIGHTENING. ALL THE FRAGMENTS WERE RETRIEVED. THE DEFECTIVE ITEM WAS REMOVED AND REPLACED. THIS RESULTED IN A PROCEDURAL DELAY OF 30 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH BACKUP IMPLANTS. NO PATIENT HARM WAS REPORTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO COMPLETE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23455475 ↗MalfunctionJul 16, 2025Off-Label Use; Off-Label Use
IT WAS REPORTED ON (B)(6) 2025 THAT THE SURGEON ATTEMPTED TO USE A MARINER SET SCREWS WITH THE MEDTRONIC UNID ROD. WHILE PERFORMING THE DISTRACTION, THE SURGEON HAD TO LOCK DOWN THE MARINER SET SCREWS MULTIPLE TIMES IN ORDER TO ACHIEVE THE DISTRACTION HE NEEDED. BACK-UP WAS NOT NEEDED AS HE WAS ABLE TO GET THE MARINER SET SCREWS TO HOLD DISTRACTION. THE IMPLANT WAS NOT BROKEN, THE ISSUE DID NOT CAUSE A CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT OUTCOME HAS BEEN REPORTED TO DATE. THIS EVENT INVOLVED THE OFF-LABEL USE OF THE MARINER SET SCREWS WITH THE MEDTRONIC UNID ROD, A COMBINATION THAT HAS NOT BEEN VALIDATED OR TESTED FOR CROSS-COMPATIBILITY. NO PATIENT INJURY, EXPLANTATION, OR ADDITIONAL INTERVENTION WAS REQUIRED. AS THE COMBINATION HAS NOT BEEN VALIDATED OR TESTED FOR CROSS-COMPATIBILITY, ORTHOFIX/SEASPINE CANNOT GUARANTEE THE STABILITY OF THE CONSTRUCT POST-OPERATIVELY, THEREFORE, BASED ON THIS RISK CHARACTERIZATION, THE EVENT WAS DETERMINED TO BE REPORTABLE. THE REP CONFIRMED THE UNID ROD AND THE MARINER SET SCREWS WERE LEFT IN-SITU AND ARE NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22526694 ↗MalfunctionJun 23, 2025Difficult or Delayed Positioning; Damaged Thread; Difficult or Delayed Positioning; Damaged Thread
A PATIENT UNDERWENT SPINAL SURGERY ON (B)(6) 2025 CONSISTING OF ORTHOFIX/SEASPINE'S MARINER PEDICLE SCREW SYSTEM. IT WAS REPORTED ON (B)(6) 2025 THAT THE SURGEON HAD DIFFICULTY PLACING SEVERAL SET SCREWS, RESULTING IN A PROCEDURAL DELAY. THE PROCEDURE WAS ULTIMATELY COMPLETED WITHOUT PATIENT INJURY, AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22307383 ↗MalfunctionJan 7, 2025Migration; Migration
A PATIENT UNDERWENT AN INITIAL SURGERY ON AN UNKNOWN DATE AND WAS SCHEDULED FOR A REVISION ADJACENT LEVEL SURGERY. WHILE PERFORMING THE REVISION SURGERY, THE SURGEON NOTICED THAT A MARINER SET SCREW HAD POPPED OFF POST-OPERATIVELY. CUSTOMER CONFIRMS THERE WAS NO PATIENT INJURY, NO DELAY IN SURGERY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. DATE OF INITIAL SURGERY AND REVISION SURGERY WERE UNABLE TO BE PROVIDED. ALTHOUGH REQUESTED, THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21093776 ↗MalfunctionJan 7, 2025Migration; Migration
A PATIENT UNDERWENT AN INITIAL SURGERY ON (B)(6) 2024 AND WAS SCHEDULED FOR A REVISION ADJACENT LEVEL SURGERY ON (B)(6) 2024. WHILE PERFORMING THE REVISION SURGERY, THE SURGEON NOTICED THAT A MARINER SET SCREW HAD POPPED OFF POST-OPERATIVELY. CUSTOMER CONFIRMS THERE WAS NO PATIENT INJURY, NO DELAY IN SURGERY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ALTHOUGH REQUESTED, THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21093775 ↗MalfunctionSep 19, 2024Migration; Migration
ON (B)(6) 2024, IT WAS OBSERVED VIA X-RAY THAT THERE WAS A POTENTIAL LOOSENING/MIGRATION OF A MARINER MIS ROD IN A PATIENT. THE SURGEON SCHEDULED A REVISION SURGERY ON (B)(6) 2024. CUSTOMER REPORTS PATIENT IS ASYMPTOMATIC AND THERE WAS NO ALLEGED PATIENT INJURY. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. SEE MDR 3012120772-2024-0068 FOR PN MM1-155035, 3012120772-2024-00085 FOR ONE OF THE RETURNED PN MD1-100016, 3012120772-2024-00086 FOR PN MM1-000020 AND 3012120772-2024-00087 FOR PN 41-7555-2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20258443 ↗MalfunctionSep 19, 2024Migration; Migration
ON (B)(6) 2024, IT WAS OBSERVED VIA X-RAY THAT THERE WAS A POTENTIAL LOOSENING/MIGRATION OF A MARINER MIS ROD IN A PATIENT. THE SURGEON SCHEDULED A REVISION SURGERY ON (B)(6) 2024. CUSTOMER REPORTS PATIENT IS ASYMPTOMATIC AND THERE WAS NO ALLEGED PATIENT INJURY. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. SEE MDR 3012120772-2024-0068 FOR PN MM1-155035, 3012120772-2024-00085 FOR ONE OF THE RETURNED PN MD1-100016, 3012120772-2024-00086 FOR PN MM1-000020,AND 3012120772-2024-00088 FOR THE SECOND RETURNED PN MD1-100016.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20258335 ↗MalfunctionSep 19, 2024Migration; Migration
ON (B)(6) 2024, IT WAS OBSERVED VIA X-RAY THAT THERE WAS A POTENTIAL LOOSENING/MIGRATION OF A MARINER MIS ROD IN A PATIENT. THE SURGEON SCHEDULED A REVISION SURGERY ON (B)(6) 2024. CUSTOMER REPORTS PATIENT IS ASYMPTOMATIC AND THERE WAS NO ALLEGED PATIENT INJURY. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. MDR 3012120772-2024-0068 FOR PN MM1-155035, 3012120772-2024-00086 FOR PN MM1-000020, 3012120772-2024-00087 FOR PN 41-7555-2 AND 3012120772-2024-00088 FOR THE SECOND RETURNED PN MD1-100016.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20258239 ↗MalfunctionJun 27, 2024Migration; Migration
ON (B)(6) 2023, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER POSTERIOR FIXATION SYSTEM. ON (B)(6) 2024, THE REPORTER PROVIDED X-RAY IMAGES THAT SHOWED POST-OPERATIVE SET SCREW BACKOUT. REVISION SURGERY IS NOT PLANNED AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19629774 ↗MalfunctionJun 21, 2024Migration; Migration
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER MIS POSTERIOR FIXATION SYSTEM. ON OR AROUND ON (B)(6) 2024, IT WAS OBSERVED THAT "THERE WAS A TULIP DISENGAGEMENT AND SET SCREW FALL OUT POST OP." REVISION SURGERY OCCURRED ON (B)(6) 2024. NO PATIENT INJURY WAS REPORTED. 10 MD1-100016 POINTLOCK SET SCREWS AND 10 MM1-000020 MIS POLYAXIAL HEADS WERE RETURNED; AT THE TIME OF THE INITIAL REPORT IT WAS UNKNOWN WHICH UNITS WERE ASSOCIATED WITH THE FAILURE. THIS REPORT IS FOR LOT: AW167907B, 3 OF 4 UNITS.
Patient problems: Insufficient Information
MAUDE report 19587598 ↗
Other Seaspine Orthopedics Corporation products
- Daytona Small Stature3 models · 14 reports · 2 recalls
- Fathom3 models · 2 reports · 2 recalls
- NorthStar24 models · 15 reports · 1 recall
- Meridian8 models · 8 reports · 1 recall
- Mariner Deformity3 models · 2 reports · 1 recall
- Mariner RDX6 models · 0 reports · 1 recall
- Virata25 models · 0 reports · 1 recall
- Reef TA2 models · 0 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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