Mariner MIS MM1-000020Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10889981177805), received between Jun 21, 2024 and Nov 25, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Migration” (11 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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 MM1-000020 MIS POLYAXIAL HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646594 ↗
• MalfunctionFeb 21, 2025Premature Separation; Premature Separation

  CUSTOMER REPORTS THAT DURING A SURGERY THAT TOOK PLACE AROUND (B)(6) 2025 (EXACT DATE OF SURGERY NOT PROVIDED), THE SURGEON NOTED ON THE FINAL X-RAY THAT THE TULIP ON THE MARINER MIS POLYAXIAL HEAD DISASSOCIATED FROM THE SHANK OF THE MARINER 6.50 X 45MM CANNULATED SCREW. THE SURGEON CHOSE TO LEAVE THE CONSTRUCT AS-IS AS THE PATIENT WAS ALREADY CLOSED UP. THERE WAS NO DELAY IN SURGERY AND NO PATIENT INJURY REPORTED. THE SURGEON DOES NOT PLAN TO PERFORM REVISION SURGERY AT THIS TIME. ALTHOUGH THREE FOLLOW-UP ATTEMPTS WERE PERFORMED, NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS EVENT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434816 ↗
• 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, 3012120772-2024-00085 FOR ONE OF THE RETURNED PN MD1-100016, 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 20258441 ↗
• 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 (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 1 OF 1 UNIT OF LOT TE183436E.

  Patient problems: Insufficient Information

  MAUDE report 19590331 ↗
• 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 (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. MULTIPLE PRODUCTS WERE EXPLANTED AND RETURNED; IT IS UNKNOWN WHICH UNITS WERE ASSOCIATED WITH THE FAILURE. THIS REPORT IS FOR 6 OF 7 UNITS OF LOT TE183452E.

  Patient problems: Insufficient Information

  MAUDE report 19590287 ↗
• 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 (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 4 OF 7 UNITS OF LOT TE183452E.

  Patient problems: Insufficient Information

  MAUDE report 19590076 ↗
• 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 (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 1 OF 7 UNITS OF LOT TE183452E.

  Patient problems: Insufficient Information

  MAUDE report 19589168 ↗
• 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 (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 3 OF 7 UNITS OF LOT TE183452E.

  Patient problems: Insufficient Information

  MAUDE report 19588941 ↗
• 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 (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 7 OF 7 UNITS OF LOT TE183452E.

  Patient problems: Insufficient Information

  MAUDE report 19587991 ↗
• 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 (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 2 OF 7 UNITS OF LOT TE183452E.

  Patient problems: Insufficient Information

  MAUDE report 19586996 ↗
• 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 (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 5 OF 7 UNITS OF LOT TE183452E.

  Patient problems: Insufficient Information

  MAUDE report 19586533 ↗
• 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 (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 2 OF 2 UNITS LOT TE183435E.

  Patient problems: Insufficient Information

  MAUDE report 19586312 ↗
• 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 (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 1 OF 2 UNITS LOT TE183435E.

  Patient problems: Insufficient Information

  MAUDE report 19586127 ↗