Mariner 41-1010Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 10889981155100), received between Dec 7, 2018 and May 30, 2024 — classified as 1 death, 19 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Migration” (29 reports).

1 other recall cover devices cleared under the same FDA submission (K173882); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2024Migration; Migration

  ON 02 MAY 2024, SEASPINE WAS MADE AWARE THAT A CUSTOMER UTILIZING THE MARINER MIS POSTERIOR FIXATION SYSTEM WAS EXPERIENCING AN "ISSUE WITH THE SET SCREWS LOWERING." MULTIPLE REQUESTS WERE MADE FOR CLARIFICATION, NO FURTHER INFORMATION WAS PROVIDED. IT IS PRESUMED THAT THE CUSTOMER MEANT "SET SCREW LOOSENING." CURRENTLY, NO REVISION SURGERIES ARE PLANNED, AND NO RETURNS ARE EXPECTED.

  Patient problems: Insufficient Information

  MAUDE report 19427282 ↗
• MalfunctionJan 5, 2024Migration; Migration

  ON 13 DEC 2023, SEASPINE WAS MADE AWARE OF TWO SET SCREW LOOSENING EVENTS INVOLVING THE MARINER POSTERIOR FIXATION SYSTEM. THIS REPORT IS FOR THE SECOND PATIENT. IT WAS NOTED THAT A ROD HAD COME LOOSE, AND ADDITIONAL SURGERY IS REQUIRED. THE INITIAL SURGERY OCCURRED ON (B)(6) 2023; THE REVISION SURGERY HAS NOT YET BEEN SCHEDULED.

  Patient problems: Insufficient Information

  MAUDE report 18456899 ↗
• MalfunctionAug 22, 2023Separation Problem; Separation Problem

  THIS EVENT WAS ORIGINALLY REPORTED ON 3012120772-2022-00019. THIS REPORT IS FOR 3 OF 5 LOT NUMBERS. A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S MARINER PEDICLE SCREW SYSTEM ON (B)(6) 2021. SEASPINE WAS MADE AWARE ON 11 APR 2022 THAT SET SCREWS HAD LOOSENED FROM THE CONSTRUCT IN THE POSTOPERATIVE PERIOD. THIS WAS NOTED AT THE 6-MONTH POST-OPERATIVE APPOINTMENT. ON 12 MAY 2022 SEASPINE WAS MADE AWARE THAT A REVISION SURGERY HAD OCCURRED ON (B)(6) 2022. EXPLANTS WERE RETURNED ON (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 17599745 ↗
• MalfunctionAug 22, 2023Separation Problem; Separation Problem

  THIS EVENT WAS ORIGINALLY REPORTED ON 3012120772-2022-00019. THIS REPORT IS FOR 2 OF 5 LOT NUMBERS. A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S MARINER PEDICLE SCREW SYSTEM ON (B)(6) 2021. SEASPINE WAS MADE AWARE ON(B)(6) 2022 THAT SET SCREWS HAD LOOSENED FROM THE CONSTRUCT IN THE POSTOPERATIVE PERIOD. THIS WAS NOTED AT THE 6-MONTH POST-OPERATIVE APPOINTMENT. ON (B)(6) 2022 SEASPINE WAS MADE AWARE THAT A REVISION SURGERY HAD OCCURRED ON (B)(6) 2022. EXPLANTS WERE RETURNED ON (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 17599683 ↗
• MalfunctionAug 22, 2023Separation Problem; Separation Problem

  THIS EVENT WAS ORIGINALLY REPORTED ON 3012120772-2022-00019. THIS REPORT IS FOR 5 OF 5 LOT NUMBERS. A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S MARINER PEDICLE SCREW SYSTEM ON (B)(6) 2021. SEASPINE WAS MADE AWARE ON (B)(6) 2022 THAT SET SCREWS HAD LOOSENED FROM THE CONSTRUCT IN THE POSTOPERATIVE PERIOD. THIS WAS NOTED AT THE 6-MONTH POST-OPERATIVE APPOINTMENT. ON (B)(6) 2022 SEASPINE WAS MADE AWARE THAT A REVISION SURGERY HAD OCCURRED ON (B)(6) 2022. EXPLANTS WERE RETURNED ON (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 17599266 ↗
• MalfunctionAug 22, 2023Premature Separation; Premature Separation

  SEASPINE WAS MADE AWARE OF A POST-OP LOOSENING EVENT ON (B)(6) 2022 THAT OCCURRED 5 MONTHS ((B)(6) 2022) PRIOR TO THE EVENT DATE ((B)(6) 2022). THE CASE WAS FOR FRACTURE AT L4 ON A 46 YEAR OLD MALE. IT WAS COMPLETED IN A PERCUTANEOUS FASHION USING THE LARGEST SCREWS THE PEDICLE WOULD HOLD AS WELL AS A 6.0COCR ROD. A 105 IN/LB TORQUE WAS USED ON REGULAR SET CAPS TO FINAL LOCK EVERYTHING. THIS REPORT IS FOR 1 OF 2 LOT NUMBERS PROVIDED. THIS REPORT WAS ORGINALLY FILED UNDER 3012120772-2022-00031 BUT REPORTED TWO LOT NUMBERS. THIS REPORT SEPARATES OUT LOT AW135865D. LOT AW135871D IS REPORTED ON 3012120772-2023-00018.

  Patient problems: Insufficient Information

  MAUDE report 17599212 ↗
• MalfunctionAug 22, 2023Separation Problem; Separation Problem

  THIS EVENT WAS ORIGINALLY REPORTED ON 3012120772-2022-00019. THIS REPORT IS FOR 4 OF 5 LOT NUMBERS. A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S MARINER PEDICLE SCREW SYSTEM ON (B)(6) 2021. SEASPINE WAS MADE AWARE ON (B)(6) 2022 THAT SET SCREWS HAD LOOSENED FROM THE CONSTRUCT IN THE POSTOPERATIVE PERIOD. THIS WAS NOTED AT THE 6-MONTH POST-OPERATIVE APPOINTMENT. ON 12 MAY 2022 SEASPINE WAS MADE AWARE THAT A REVISION SURGERY HAD OCCURRED ON (B)(6) 2022. EXPLANTS WERE RETURNED ON 16MAY2022.

  Patient problems: Failure of Implant

  MAUDE report 17599206 ↗
• MalfunctionAug 22, 2023Separation Problem; Separation Problem

  THIS EVENT WAS ORIGINALLY REPORTED ON 3012120772-2022-00019. THIS REPORT IS FOR 1 OF 5 LOT NUMBERS. A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S MARINER PEDICLE SCREW SYSTEM ON (B)(6) 2021. SEASPINE WAS MADE AWARE ON 11 APR 2022 THAT SET SCREWS HAD LOOSENED FROM THE CONSTRUCT IN THE POSTOPERATIVE PERIOD. THIS WAS NOTED AT THE 6-MONTH POST-OPERATIVE APPOINTMENT. ON 12 MAY 2022 SEASPINE WAS MADE AWARE THAT A REVISION SURGERY HAD OCCURRED ON (B)(6) 2022. EXPLANTS WERE RETURNED ON 16MAY2022.

  Patient problems: Failure of Implant

  MAUDE report 17599175 ↗
• MalfunctionAug 22, 2023Premature Separation; Premature Separation

  SEASPINE WAS MADE AWARE OF A POST-OP LOOSENING EVENT ON (B)(6) 2022 AT OCCURRED 5 MONTHS ((B)(6) 2022) PRIOR TO THE EVENT DATE ((B)(6) 2022). THE CASE WAS FOR FRACTURE AT L4 ON A 46 YEAR OLD MALE. IT WAS COMPLETED IN A PERCUTANEOUS FASHION USING THE LARGEST SCREWS THE PEDICLE WOULD HOLD AS WELL AS A 6.0COCR ROD. A 105 IN/LB TORQUE WAS USED ON REGULAR SET CAPS TO FINAL LOCK EVERYTHING. THIS REPORT IS FOR 2 OF 2 LOT NUMBERS PROVIDED. THIS REPORT WAS "ORIGINALLY" FILED UNDER 3012120772-2022-00031 BUT REPORTED TWO LOT NUMBERS. THIS REPORT SEPARATES OUT LOT AW135871D. LOT AW135865D WAS REPORTED ON 3012120772-2023-00024.

  Patient problems: Insufficient Information

  MAUDE report 17599098 ↗
• InjuryJan 31, 2023Migration; Migration

  SEASPINE WAS MADE AWARE ON (B)(6) 2023 THAT A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF A SEASPINE MARINER MIS SYSTEM. THE INDEX SURGERY WAS ON (B)(6) 2022. THE DISTRIBUTOR REPORTED THAT A CONSTRUCT FAILURE OCCURRED POST-OPERATIVELY. THE X-RAYS PROVIDED APPEAR TO SHOW THAT THE P/N: 41-1010 SET SCREW LOOSENED AT L4.

  Patient problems: Insufficient Information

  MAUDE report 16273161 ↗
• InjuryDec 22, 2022Migration; Migration

  PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER PEDICLE SCREW SYSTEM ON (B)(6) 2022. ON (B)(6) 2022 IT WAS IDENTIFIED THAT THE S1 SET SCREW LOOSENED, CAUSING THE ROD TO DISENGAGE FROM THE SUPERIOR TULIP HEAD AND SLID INFERIORLY. REMOVAL AND RE-INSTRUMENTATION OF THE FIXATION OCCURRED ON (B)(6) 2022. SEASPINE WAS MADE AWARE OF THIS EVENT ON (B)(6) 2022. THERE WERE 2 SCREWS AND 1 ROD P/N MM1-155040) INVOLVED IN THIS SINGLE EVENT. LOT NUMBERS AW154138D/AW127247D.

  Patient problems: Insufficient Information

  MAUDE report 16039948 ↗
• InjuryDec 22, 2022Migration; Migration

  SEASPINE WAS MADE AWARE OF AN EVENT INVOLVING MULTIPLE SET SCREWS LOOSENING POST-OPERATIVELY. THE INDEX SURGERY WAS ON (B)(6) 2022 AND THE EVENT DATE IS ON (B)(6) 2022 THERE WERE 10 SCREWS OVER 6 LOTS INVOLVED AND ARE AS FOLLOWS: PRODUCT LOT NUMBER PRODUCT QUANTITY AW155418D 4, AW154141D 2, AW132005D 1, AW147643D 1, AW154681D 1, AW154138D 1. THIS PATIENT HAD A PRIOR FUSION FROM L2-L4. THEY HAD A PREVIOUS FRACTURE AT T12 WHICH WAS CEMENTED. THEY KYPHOSED ABOVE THEIR HARDWARE AT L1. L1 AND L2 SUBSEQUENTLY FUSED TOGETHER. IF I REMEMBER CORRECTLY[?]THEY ALSO HAD SOME CERVICAL WORK DOWN THAT'S NOT SHOWN.

  Patient problems: Insufficient Information

  MAUDE report 16039921 ↗
• MalfunctionNov 23, 2022Premature Separation; Premature Separation

  ON (B)(6) 2022 THE SEASPINE CLINICAL TEAM PROVIDED AN UPDATED SAE FORM FOR PATIENT (B)(6). THE EVENT DESCRIPTION IN THE UPDATED FORM NOTED THAT ON (B)(6) 2021 THE PATIENT HAS PLATEAUED IN IMPROVEMENT WITH PAIN ON THE LEFT SIDE LOW BACK. ALSO, NOTED BILATERAL SET NUT LOOSENING AT L5. REVISION TO BE CONSIDERED IF THE PATIENT DOES NOT CONTINUE TO IMPROVE. AT THAT TIME THE PATIENT CONTINUED PHYSICAL THERAPY AND THE HOPE WAS THAT BRACING WITH THE INTERBODY FUSION WOULD LEAD TO A SOLID FUSION AND REDUCTION IN PAIN. NOTE THAT THE INITIAL LEFT L5 SET SCREW LOOSENING WAS RECORDED UNDER PR (B)(4). TREATMENT DESCRIPTION: REVISION POSTERIOR SPINAL FUSION L5-S1 WITH HARDWARE REMOVAL AND REINSERTION WITH ANOTHER SYSTEM.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15854374 ↗
• MalfunctionSep 13, 2022Separation Failure; Premature Separation; Separation Failure; Premature Separation

  SEASPINE WAS NOTIFIED ON (B)(6) 2022 OF A SCREW BACK OUT EVENT. ON THE FILMS PROVIDED, THERE WAS ALSO A ROD FRACTURE OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 15415031 ↗
• MalfunctionMay 9, 2022Premature Separation; Premature Separation

  A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S MARINER PEDICLE SCREW SYSTEM ON (B)(6) 2021 . SEASPINE WAS MADE AWARE ON (B)(6) 2022 THAT SET SCREWS HAD LOOSENED FROM THE CONSTRUCT IN THE POSTOPERATIVE PERIOD.

  Patient problems: Failure of Implant

  MAUDE report 14342789 ↗
• InjuryApr 7, 2022Premature Separation; Premature Separation

  A PATIENT UNDERWENT A 5 LEVEL SPINAL SURGERY FROM LEVEL L1-S1 ON (B)(6) 2021 CONSISTING OF SEASPINE'S MARINER PEDICLE SCREW SYSTEM. SEASPINE WAS MADE AWARE OF A REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2022 DUE TO IMPLANTS LOOSENING FROM THE CONSTRUCT IN THE POSTOPERATIVE PERIOD.

  Patient problems: Failure of Implant

  MAUDE report 14043451 ↗
• MalfunctionMar 23, 2022Premature Separation; Premature Separation

  A PATIENT UNDERWENT A 3 LEVEL SPINAL SURGERY FROM LEVEL L3-L5 ON (B)(6) 2021 CONSISTING OF SEASPINE'S MARINER PEDICLE SCREW SYSTEM. SEASPINE WAS MADE AWARE ON 25 FEB 2022 THAT THE TWO SET SCREWS AT THE L3 LEVEL LOOSENED FROM THE CONSTRUCT IN THE POSTOPERATIVE PERIOD.

  Patient problems: Failure of Implant

  MAUDE report 13857946 ↗
• InjuryFeb 3, 2022Premature Separation; Premature Separation

  A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER PEDICLE SCREW SYSTEM AND SEASPINE'S REGATTA AND REEF TO INTERVERTEBRAL FUSION DEVICES ON (B)(6) 2020. ON (B)(6) 2022, IT WAS REPORTED THAT A REVISION SURGERY OCCURRED ON (B)(6) 2020 TO REPLACE THREE MARINER SET SCREWS THAT LOOSENED IN THE POSTOPERATIVE PERIOD. TWO OF THE THREE SET SCREWS REPORTEDLY LOOSENED A SECOND TIME, PROMPTING A SECOND REVISION SURGERY, WHICH OCCURRED ON (B)(6) 2022, PROMPTING REPORT 3012120772-2022-00001.

  Patient problems: Failure of Implant

  MAUDE report 13444909 ↗
• InjuryFeb 3, 2022Premature Separation; Premature Separation

  A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER PEDICLE SCREW SYSTEM AND SEASPINE'S REGATTA AND REEF TO INTERVERTEBRAL FUSION DEVICES ON (B)(6) 2020. ON (B)(6) 2022, IT WAS REPORTED THAT A REVISION SURGERY OCCURRED ON (B)(6) 2020 TO REPLACE THREE MARINER SET SCREWS THAT LOOSENED IN THE POSTOPERATIVE PERIOD (REF: 3012120772-2022-00002 FOR THIS EVENT). TWO OF THE THREE SET SCREWS REPORTEDLY LOOSENED AGAIN, PROMPTING A SECOND REVISION SURGERY, WHICH OCCURRED ON (B)(6) 2022, PROMPTING THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 13444889 ↗
• MalfunctionNov 9, 2021Mechanical Problem; Mechanical Problem

  PATIENT UNDERWENT INITIAL PROCEDURE ON (B)(6) 2020. DURING FOLLOW-UP CT SCAN, IT WAS NOTICED BY THE SURGEON, THAT THE SET SCREW NO LONGER LOCKED INTO THE POLYAXIAL HEAD. THE SURGEON DECIDED TO REOPERATE ON THIS PATIENT, TO REMOVE THE SET SCREW AND POLYAXIAL HEAD AND REPLACE WITH THE NEW ONES. THE REASON FOR THE LOOSENING IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12782870 ↗
• MalfunctionOct 21, 2021Separation Problem; Separation Problem

  DOCTOR CONDUCTED A REMOVAL OF IMPLANTS ON A PATIENT THAT HAD AN L3-S1 ALIF + POST SCREW FIXATION WITH MIS MARINER ON (B)(6) 2021. UPON REMOVING THE S1 AND L5 SCREWS, HE NOTICED THAT THE SET SCREWS HAD LOOSENED SIGNIFICANTLY. ALTHOUGH THE SET SCREWS DID NOT FULLY REMOVE, THE THERE WAS NO TORQUE RETAINED ON THE IMPLANTS. OF NOTE, THE INDEX SURGERY WAS PERFORMED WITH 85LB TORQUE LIMITERS ON (B)(6) 2020. IMAGES WERE PROVIDED THAT SHOW THE BOTTOMS OF THE SET SCREWS THAT WERE LOOSE.

  Patient problems: Failure of Implant

  MAUDE report 12677646 ↗
• MalfunctionSep 16, 2021Separation Problem; Separation Problem

  SURGEON REPORTED THAT A SET SCREW BACKOUT OCCURRED APPROXIMATELY 6 MONTHS POST-OPERATION. THE REPORT NOTED THE LOOSENING OCCURRED AT THE BOTTOM OF THE CONSTRUCT. WHILE SURGICAL REVISION IS PLANNED, THERE IS NO DEFINITIVE DATE FOR THE SURGERY BETWEEN THE DATE THAT THE ISSUE WAS REPORTED AND THE TIME OF THIS REPORT. THERE WERE NO PRODUCTS RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 12481904 ↗
• MalfunctionAug 27, 2021Separation Problem; Separation Problem

  ON (B)(6) 2021, IT WAS REPORTED THAT BACKED OUT SCREWS WERE OBSERVED DURING A PROCEDURE. THERE WERE NO RESPONSES FROM THE REPORTER OR THE FACILITY TO FOLLOW UP ATTEMPTS REQUESTING FURTHER INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 12380783 ↗
• MalfunctionJul 6, 2021Loose or Intermittent Connection; Separation Problem; Loose or Intermittent Connection; Separation Problem

  PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021, FOR UNSPECIFIED REASONS AT WHICH TIME IT WAS NOTED THAT 1 OUT OF 6 LOCK SCREWS HAD BACKED OUT. THE PRODUCT IS NOT AVAILABLE FOR RETURN. THE REASON FOR THE REVISION SURGERY IS UNKNOWN AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 12124751 ↗
• MalfunctionJun 9, 2021Separation Problem; Separation Problem

  A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER PEDICLE SCREW SYSTEM FROM LEVELS L3-L5. A LATERAL X-RAY REVEALED THAT A SET SCREW MIGRATED IN THE POSTOPERATIVE PERIOD.

  Patient problems: Failure of Implant

  MAUDE report 11970405 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173882. One submission often covers many models, so check the product and lot details in each record.

• Z-2762-2026 · May 28, 2026 · Open, Classified
  SeaSpine Polyaxial Head REF Number: 41-3010