Mariner 41-1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10889981065065), received between Jul 20, 2017 and May 5, 2021 — classified as 5 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (19 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.

Most reported problems

Recent adverse event reports

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

• InjuryMay 5, 2021Separation Failure; Premature Separation; Separation Failure; Premature Separation

  A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER PEDICLE SCREW SYSTEM ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT HEARD POPS AND FELT PAIN POSTOPERATIVELY. DURING A 4-WEEK FOLLOW UP APPOINTMENT, IT WAS DISCOVERED THAT 2 SET SCREWS SEPARATED FROM THE CONSTRUCT. THE SURGEON AND PATIENT ELECTED TO PROCEED WITH A REVISION SURGERY, WHICH TOOK PLACE ON (B)(6) 2021 AND CONSISTED OF EXPLANTING THE SEASPINE HARDWARE AND REPLACING WITH ANOTHER MANUFACTURER'S. THE SEASPINE EXPLANTS WERE RETURNED TO SEASPINE FOR ANALYSIS ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 11780920 ↗
• MalfunctionAug 20, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2018, THE PATIENT UNDERWENT A ONE-LEVEL, POSTERIOR LUMBAR FUSION USING THE MARINER PEDICLE SCREW SYSTEM. DURING THE ONE-YEAR FOLLOW-UP APPOINTMENT, RADIOGRAPHS WERE TAKEN, AND IT WAS OBSERVED THAT A SET-SCREW HAD BACKED-OUT POST-OPERATIVELY. AT THE TIME OF CONTACT, A REVISION SURGERY HAD NOT BEEN PERFORMED AND IT WAS UNKNOWN IF THE SURGEON HAD PLANS TO REVISE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 8913475 ↗
• InjuryJul 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  INDEX SURGERY OCCURRED ON (B)(6) 2017, WHICH INCLUDED A PARTIAL L4-5 DECOMPRESSIVE LUMBAR LAMINECTOMY, LEFT L5-S1 MICROFORAMINOTOMY, L4 TO S1 PEDICLE INSTRUMENTATION AND FACET FUSION. ACCORDING TO THE LEGAL DOCUMENT RECEIVED, BILATERAL SET SCREWS WERE BROKEN, AND RODS WERE BENT. IT IS UNKNOWN HOW THE DISCOVERY OF BROKEN SET SCREWS AND BENT RODS WERE IDENTIFIED, AS NO IMAGES OR MEDICAL EVALUATION WERE PROVIDED. ACCORDING TO THE LEGAL DOCUMENT RECEIVED, THE PATIENT SUSTAINED INJURIES WHICH RESULTED IN PAIN, REQUIRING SURGICAL INTERVENTION. REVISION OCCURRED ON (B)(6) 2018, WHICH INCLUDED REMOVAL OF MANUFACTURER'S FIXATION SYSTEM. CURRENT PATIENT CONDITION IS UNKNOWN.

  Patient problems: Failure of Implant; Patient Problem/Medical Problem

  MAUDE report 8786991 ↗
• InjuryJul 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  INDEX SURGERY OCCURRED ON (B)(6) 2017, WHICH INCLUDED A PARTIAL L4-5 DECOMPRESSIVE LUMBAR LAMINECTOMY, LEFT L5-S1 MICROFORAMINOTOMY, L4 TO S1 PEDICLE INSTRUMENTATION AND FACET FUSION. ACCORDING TO THE LEGAL DOCUMENT RECEIVED, BILATERAL SET SCREWS WERE BROKEN, AND RODS WERE BENT. IT IS UNKNOWN HOW THE DISCOVERY OF BROKEN SET SCREWS AND BENT RODS WERE IDENTIFIED, AS NO IMAGES OR MEDICAL EVALUATION WERE PROVIDED. ACCORDING TO THE LEGAL DOCUMENT RECEIVED, THE PATIENT SUSTAINED INJURIES WHICH RESULTED IN PAIN, REQUIRING SURGICAL INTERVENTION. REVISION OCCURRED ON (B)(6)2018, WHICH INCLUDED REMOVAL OF MANUFACTURER'S FIXATION SYSTEM. CURRENT PATIENT CONDITION IS UNKNOWN.

  Patient problems: Failure of Implant; Patient Problem/Medical Problem

  MAUDE report 8786028 ↗
• InjuryFeb 27, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2018, THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION FROM LEVELS T9 THROUGH S1 USING THE MARINER PEDICLE SCREW SYSTEM. THE PATIENT HAD SUBSEQUENT FOLLOW-UP APPOINTMENTS AND RADIOGRAPHS WERE TAKEN ON (B)(6) 2018, (B)(6) 2018 AND (B)(6) 2018. ON (B)(6) 2019, IT WAS REPORTED THAT THE MARINER LOCKING CAPS HAD DISENGAGED POST-OPERATIVELY. AT THE TIME OF CONTACT, A REVISION SURGERY HAD NOT BEEN PERFORMED. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 8376184 ↗
• InjuryFeb 27, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2018, THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION FROM LEVELS T10-S1 WITH DEFORMITY CORRECTION USING THE MARINER PEDICLE SCREW SYSTEM. THE PATIENT HAD SUBSEQUENT FOLLOW-UP APPOINTMENTS AND RADIOGRAPHS WERE TAKEN ON (B)(6) 2018 AND (B)(6) 2018. IT WAS REPORTED THAT INSTRUMENTATION FAILURE OCCURRED AT THE L4-L5 AND L5-S1 LEVELS, AS THE MARINER SCREWS HAD DISENGAGED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 AND INCLUDED ANTERIOR LUMBAR INTERBODY FUSION OF L5-S1, POSTERIOR SPINAL FUSION OF L4-5 AND L5-S1, LUMBAR RE-INSTRUMENTATION OF L4-5 AND L5-S1 AND A CAUDAL EXTENSION OF FIXATION TO THE PELVIS. ADDITIONAL RADIOGRAPHS WERE TAKEN POST-SURGERY ON (B)(6) 2018 TO MONITOR THE PATIENT'S CONDITION. AT THE TIME OF CONTACT, THE PATIENT WAS REPORTED TO BE DOING FINE. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 8375949 ↗
• MalfunctionFeb 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2018, THE PATIENT UNDERWENT POSTERIOR FIXATION SURGERY FROM LEVELS T10-S1 USING THE MARINER PEDICLE SCREW SYSTEM. AT THE FOUR WEEK FOLLOW-UP APPOINTMENT, IT WAS DISCOVERED THAT A SET SCREW HAD DISASSOCIATED FROM THE SCREW TULIP. THE PATIENT HAD SUBSEQUENT FOLLOW-UP APPOINTMENTS AND RADIOGRAPHS WERE TAKEN ON (B)(6) 2018, (B)(6) 2018 AND (B)(6) 2018. PATIENT IS ASYMPTOMATIC. NO REVISION SCHEDULED AT THIS TIME. SURGEON WILL MONITOR PATIENT PROGRESS.

  Patient problems: Failure of Implant

  MAUDE report 8375795 ↗
• MalfunctionNov 1, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  INITIAL SPINAL CONSTRUCT SURGERY, COVERING LEVELS T10 - L2, WAS PERFORMED IN (B)(6) OF 2018 POST-OPERATIVE FOLLOW-UP DETERMINED A SCREW HEAD AT L2 PEDICLE HAD DETACHED FROM THE BONE SCREW. REVISION SURGERY OCCURRED ON (B)(6) 2018. REVISION SURGERY CONSISTED OF A TOTAL REMOVAL OF HARDWARE AND REPLACED WITH COMPETITOR CONSTRUCT.

  Patient problems: Failure of Implant

  MAUDE report 8031232 ↗
• MalfunctionSep 28, 2018Detachment of Device or Device Component

  FOLLOW-UP EXAM RADIOGRAPHS SHOWED THE SET SCREW DETACHED AT S1. PATIENT IS ASYMPTOMATIC. SURGEON HAS ELECTED TO MONITOR PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7920367 ↗
• MalfunctionAug 1, 2018Mechanical Problem; Mechanical Problem

  INITIAL SURGERY WAS PERFORMED FROM IN (B)(6) 2017 AND PATIENT WAS INSTRUMENTED WITH POSTER FIXATION.

  Patient problems: No Information

  MAUDE report 7741016 ↗
• MalfunctionJul 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  INITIAL SURGERY WAS PERFORMED FROM L2 - S1 IN (B)(6) 2017 AND PATIENT WAS INSTRUMENTED WITH POSTER FIXATION. IN (B)(6) 2018 REVISION SURGERY WAS COMPLETED TO CORRECT POSTERIOR FIXATION.

  Patient problems: Failure of Implant

  MAUDE report 7708369 ↗
• MalfunctionJun 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  INITIAL SPINAL SURGERY WAS PERFORMED ON L3 - S1 ON (B)(6) 2018. DURING A FOLLOW UP, IT WAS DISCOVERED THE INFERIOR LEFT SET SCREW AND ROD DISLODGED FROM THE TULIP. REVISION SURGERY WAS COMPETED ON (B)(6) 2018 TO RE-FIXATE THE LOCK SCREW AND POSITION ROD INTO TULIP. PATIENT WAS ASYMPTOMATIC.

  Patient problems: Failure of Implant

  MAUDE report 7580924 ↗
• MalfunctionMar 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

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  Patient problems: Failure of Implant

  MAUDE report 7356106 ↗
• MalfunctionMar 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2018 PATIENT UNDERWENT A TWO LEVEL SPINAL FUSION WITH POSTERIOR FIXATION. DURING FOLLOW UP IT WAS DISCOVERED A LOCK SCREW WAS LOOSE. REVISION SURGERY WAS PERFORMED TO RE-FIXATE THE LOCK SCREW ON (B)(6) 2018. PATIENT WAS ASYMPTOMATIC.

  Patient problems: Failure of Implant

  MAUDE report 7356015 ↗
• MalfunctionMar 16, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  SPINAL FUSION WAS PERFORMED FROM L2-S1 ON (B)(6) 2017 AND PATIENT WAS INSTRUMENTED WITH POSTERIOR FIXATION. ON (B)(6) 2017 THE LEFT S1 SET SCREW LOOSENED AND ROD DISLODGED FROM THE S1 BONE SCREW. THE PATIENT WAS REVISED AND LARGER BONE SCREW WAS IMPLANTED AND THE CONSTRUCT WAS FIXATED. DEVICE WAS DISCARDED BY THE HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 7347167 ↗
• MalfunctionMar 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  INITIAL SURGERY WAS PERFORMED FROM L3 - S1 IN (B)(6) 2017 AND PATIENT WAS INSTRUMENTED WITH POSTER FIXATION. ON (B)(6) REVISION SURGERY WAS COMPLETED TO REMOVE TWO SCREWS AT S1 THAT HAD BROKE MID-SHAFT.

  Patient problems: Failure of Implant

  MAUDE report 7329158 ↗
• MalfunctionMar 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  SPINAL FUSION WAS PERFORMED FROM L3-S1 ON (B)(6) 2017 AND PATIENT WAS INSTRUMENTED WITH POSTERIOR FIXATION. ON (B)(6) 2018 THE RIGHT S1 SET SCREW LOOSENED AND ROD DISLODGED FROM THE S1 BONE SCREW.

  Patient problems: Failure of Implant

  MAUDE report 7329060 ↗
• MalfunctionMar 1, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  SURGERY PERFORMED: PRIMARY FUSION FROM L3-S1. SET SCREW DISLODGED FROM TULIP L3 RIGHT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 7308236 ↗
• MalfunctionDec 11, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  FOLLOW-UP EXAM CT SCANS SHOWED THE LEFT SET SCREW LOOSE AND DETACHED AT S1. PATIENT IS ASYMPTOMATIC. PATIENT ADMITTEDLY SUSTAINED A FALL PRIOR TO THIS EVENT. SURGEON HAS ELECTED TO MONITOR PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 7107067 ↗
• MalfunctionNov 9, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  FOLLOW-UP EXAM ALLEGEDLY SHOWED BOTTOM SET SCREW LOOSING ON CONSTRUCT ALLOWING THE ROD TO DISASSOCIATE FROM TULIP.

  Patient problems: Failure of Implant

  MAUDE report 7016420 ↗
• MalfunctionOct 13, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORTEDLY DURING FOLLOW-UUP EXAM (A FEW WEEKS POSTOPERATIVELY), IT WAS DISCOVERED THAT THE CAVDAL LOCK SCREWS WERE LOOSE ON THE CONSTRUCT.

  Patient problems: Failure of Implant

  MAUDE report 6949919 ↗
• MalfunctionOct 9, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A SCHEDULE REVISION TO EXTEND THE CONSTRUCT FROM L4 TO L3 FOR ADJACENT SEGMENT DISEASE, THE CEPHALAD LOCK SCREW AT L4 WAS NOTED TO BE LOOSE AND DISASSOCIATED FROM THE CONSTRUCT. REVISION SURGERY WAS COMPLETE TO CORRECT THE LOOSE LOCK SCREW.

  Patient problems: Failure of Implant

  MAUDE report 6931376 ↗
• MalfunctionSep 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  FOLLOW-UP EXAM ALLEGEDLY SHOWED LOCK SCREW LOOSENING AND DISASSOCIATING FROM CONSTRUCT. NO REVISION DATE IS SET AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 6873310 ↗
• MalfunctionAug 30, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  INITIAL SURGERY ON (B)(6) 2016 INVOLVED BILATERAL POSTERIOR FIXATION. THE THREE LEVEL CONSTRUCT IN THE THORACIC REGION WAS TO TREAT COMPRESSION FRACTURE AND FOCAL KYPHOSIS . UNRELATED TO THE INDEX SURGERY, ADDITIONAL SURGERY OCCURRED AGAIN IN (B)(6) 2016 TO TREAT ADDITIONAL FRACTURES ABOVE THE (B)(6) 2016 CONSTRUCT. INTRA-OPERATIVE IMAGES DID NOT SHOW SET SCREW LOOSE. POST-OP X-RAYS ALSO DID NOT SHOW SET SCREWS LOOSE. FOLLOW-UP EXAM AND RADIOGRAPHS IN (B)(6) 2017 SHOWED LOCK SCREW LOOSENING AND DISASSOCIATING FROM CEPHALAD END OF CONSTRUCT. PATIENT IS ASYMPTOMATIC. NO REVISION IS PLANNED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 6830562 ↗
• MalfunctionJul 20, 2017Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  PRIOR TO THE INDEX SURGERY, PATIENT HAD SPINE FUSION AND EXISTING CONSTRUCT FROM L3-L5. ON (B)(6) 2017, PATIENT RECEIVED POSTERIOR LUMBAR INTERBODY FUSION (PLIF) INVOLVING TWO COMPETITOR'S (GLOBUS) EXPANDABLE INTERBODY IMPLANTS (LEFT SIDE IMPLANT HAS ROTATED AND COLLAPSED) AND COMPETITIVE (SPINE WAVE- ANNEX) ADJACENT SEGMENT ROD (L2-L3) ATTACHED TO TWO SEASPINE PEDICLE BONE SCREWS L2. AT SIX WEEKS DURING ROUTINE FOLLOW UP, RADIOGRAPHS DEPICTED A DISASSEMBLY OF THE RIGHT L2 SET SCREW. THE PATIENT WAS ASYMPTOMATIC. ON (B)(6) 2017 PATIENT WAS REVISED WITH COMPETITOR'S PRODUCT TO STABILIZE THE CONSTRUCT.

  Patient problems: Failure of Implant

  MAUDE report 6729609 ↗