MANTIS Redux 48289999Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 04546540671431), received between Feb 23, 2016 and Mar 24, 2026 — classified as 41 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Migration” (33 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 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Migration

  A HEALTH PROFESSIONAL REPORTED THAT A MANTIS REDUX BLOCKER AND AN ES2 ROD MIGRATED POST-OPERATIVELY. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS REPORT REPRESENTS THE MANTIS REDUX BLOCKER MIGRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676733 ↗
• MalfunctionFeb 27, 2026Migration

  A HEALTH PROFESSIONAL REPORTED THAT A MANTIS REDUX BLOCKER MIGRATED APPROXIMATELY TWO MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477451 ↗
• InjuryAug 4, 2025Migration; Migration

  IT WAS FURTHER REPORTED THAT THE PATIENT "HAD BEEN MOVING AFTER THE SURGERY, NOT FOLLOWING THE DOCTOR'S INSTRUCTIONS TO LIMIT HIS ACTIVITIES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22704640 ↗
• InjuryJun 17, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 6 MONTHS POST-OPERATIVELY TO ADDRESS A MIGRATED MANTIS REDUX BLOCKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 22243522 ↗
• MalfunctionNov 27, 2024Difficult to Insert; Migration; Difficult to Insert; Migration

  IT WAS REPORTED THAT THE TAB OF AN ES2 AUGMENTABLE LONG BLADE POLYAXIAL SCREW FRACTURED OFF WHEN INSERTING A MANTIS REDUX BLOCKER, AND THAT THE BLOCKER WAS DISPLACED OUT OF THE SCREW INTRA-OPERATIVELY. THE BLOCKER WAS REMOVED FROM THE PATIENT, RESULTING IN A 20 MINUTE SURGICAL DELAY, AND THE SURGEON DECIDED TO LEAVE THE SCREW WITHOUT A BLOCKER INSERTED. THIS REPORT IS FOR THE MANTIS BLOCKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793754 ↗
• MalfunctionJul 22, 2024Migration; Migration

  A COMPANY REPRESENTATIVE REPORTED THAT A MANTIS REDUX BLOCKER AT L2 MIGRATED POST-OPERATIVELY. NO ADVERSE CONSEQUENCES WERE REPORTED. THE MIGRATED BLOCKER WAS OBSERVED IN AN X-RAY TAKEN FOR A PLANNED REVISION SURGERY TO REMOVE ALL IMPLANTS AS THE PATIENT WAS REPORTED TO HAVE ACHIEVED GOOD BONE UNION. THE BLOCKER WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19799126 ↗
• InjuryJun 11, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A MIGRATED MANTIS REDUX BLOCKER AT L3 ONE DAY AFTER IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509648 ↗
• MalfunctionMay 14, 2024Migration; Migration

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST-OPERATIVELY A MANTIS REDUX BLOCKER AT LEFT L5 MIGRATED. REVISION SURGERY IS NOT SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311124 ↗
• InjuryFeb 26, 2024Migration; Migration

  A PATIENT WAS REVISED TO ADDRESS A MIGRATED MANTIS REDUX BLOCKER AT L3 APPROXIMATELY SEVEN WEEKS AFTER IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785021 ↗
• InjuryMay 12, 2023Migration; Migration

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A FRACTURED XIA 3 POLYAXIAL SCREW AT RIGHT-SIDE S1 AND A MIGRATED MANTIS REDUX BLOCKER AT LEFT-SIDE S1. THE PATIENT REPORTED EXPERIENCING LOW BACK PAIN AND INSTABILITY APPROXIMATELY TWO MONTHS POST-OPERATIVELY, AND IMAGING IDENTIFIED THE FRACTURE AND MIGRATION. THIS REPORT IS FOR THE MANTIS REDUX BLOCKER.

  Patient problems: Pain

  MAUDE report 16919798 ↗
• InjuryMay 3, 2023Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 2.5 MONTHS POST-OPERATIVELY TO ADDRESS A MIGRATED MANTIS REDUX BLOCKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865147 ↗
• InjuryDec 20, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS A MIGRATED MANTIS REDUX BLOCKER (NOTICED VIA A CT SCAN) APPROXIMATELY 11 DAYS AFTER IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014774 ↗
• InjurySep 24, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR MIGRATED MANTIS REDUX BLOCKERS APPROXIMATELY TWO MONTHS AFTER IMPLANTATION. THIS REPORT CAPTURES THE THIRD OF THE FOUR MIGRATED BLOCKERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481149 ↗
• InjurySep 24, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR MIGRATED MANTIS REDUX BLOCKERS APPROXIMATELY TWO MONTHS AFTER IMPLANTATION. THIS REPORT CAPTURES THE FOURTH OF THE FOUR MIGRATED BLOCKERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15480793 ↗
• InjurySep 24, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR MIGRATED MANTIS REDUX BLOCKERS APPROXIMATELY TWO MONTHS AFTER IMPLANTATION. THIS REPORT CAPTURES THE SECOND OF THE FOUR MIGRATED BLOCKERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15480714 ↗
• InjurySep 24, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR MIGRATED MANTIS REDUX BLOCKERS APPROXIMATELY TWO MONTHS AFTER IMPLANTATION. THIS REPORT CAPTURES THE FIRST OF THE FOUR MIGRATED BLOCKERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15480690 ↗
• InjuryAug 24, 2021Migration; Migration

  IT WAS REPORTED THAT ON CT IMMEDIATELY AFTER SURGERY, SHOWED THAT THE SCREW BLOCKER OF THE LEFT S2 WAS COMING LOOSE. THE PATIENT WAS TAKEN BACK INTO THE SURGICAL SUITE AND ANESTHESIA WAS ADDED, THE WOUND WAS REOPENED, AND THE SCREW AND BLOCKER WERE REPLACED WITH NEW ONES. THIS LED TO A 20-30 MINUTE DELAY. THIS REPORT WILL COVER THE BLOCKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362979 ↗
• MalfunctionMay 24, 2021Use of Device Problem; Migration; Use of Device Problem; Migration

  IT WAS REPORTED THAT DURING THE PROCEDURE, A MANTIS REDUX BLOCKER WAS INADVERTENTLY LEFT IN THE PATIENT. AN XRAY WAS PERFORMED AND AN ADDITIONAL SET SCREW WAS OBSERVED. REVISION IS SCHEDULED IN THE FUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872852 ↗
• InjuryApr 2, 2021Material Separation; Migration; Material Separation; Migration

  IT WAS REPORTED THAT SIX DAYS AFTER THE INITIAL SURGERY, AN ES2 BLOCKER MIGRATED FROM ITS RESPECTIVE SCREW. THE SURGEON PLANS ON REVISING THE PATIENT. UPDATE: PATIENT WAS REVISED ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610891 ↗
• MalfunctionOct 19, 2020Migration; Migration

  IT WAS REPORTED THAT A PATIENT RECEIVED REVISION SURGERY APPROXIMATELY FOUR MONTHS POST OPERATIVELY DUE TO A LOOSE SCREW. DURING THE REVISION SURGERY, THE SURGEON FOUND THAT AN ES2 INTEGRATED BLADE SCREW TULIP DISENGAGED AND A MANTIS REDUX BLOCKER MIGRATED. THE SCREWS WERE THEN REPLACED AND THE CONSTRUCT WAS EXTENDED. THIS REPORT REPRESENTS THE MANTIS REDUX BLOCKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10701964 ↗
• InjurySep 29, 2020Migration; Migration

  A PHYSICIAN REPORTED THAT A MANTIS REDUX BLOCKER MIGRATED TWO DAYS AFTER IMPLANTATION AND THAT, "THE BLOCKER MAY HAVE BEEN SLANTED WITH RESPECT TO THE ROD WHEN THE BLOCKER WAS INSERTED." THE PATIENT HAS BEEN REVISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10602833 ↗
• InjuryAug 10, 2020Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT PRESENTED TO THE HOSPITAL WITH "COMPLAINTS". UPON REVIEW OF XRAY, IT WAS OBSERVED THAT TWO XIA 3 TITANIUM BLOCKERS HAD COME LOOSE FROM THE SCREW HEAD. REVISION SURGERY HAS BEEN PERFORMED. THIS REPORT CAPTURES THE SECOND OF TWO BLOCKERS.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10384493 ↗
• InjuryAug 10, 2020Migration; Migration

  IT WAS REPORTED THAT A PATIENT PRESENTED TO THE HOSPITAL WITH "COMPLAINTS". UPON REVIEW OF XRAY, IT WAS OBSERVED THAT TWO XIA 3 TITANIUM BLOCKERS HAD COME LOOSE FROM THE SCREW HEAD. REVISION SURGERY HAS BEEN PERFORMED. THIS REPORT CAPTURES THE FIRST OF TWO BLOCKERS.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10384492 ↗
• InjuryMay 22, 2020Migration; Migration

  IT WAS REPORTED THAT TWO MANTIS SCREWS AND A MANTIS REDUX BLOCKER MIGRATED POST-OPERATIVELY. TWO MONTHS AFTER INITIAL SURGERY, THE PATIENT EXPERIENCED A BONE FRACTURE AFTER EXCESSIVE HIP MOVEMENT/ROTATION THAT CAUSED THE TWO SCREWS AND BLOCKER TO BECOME LOOSE. THE PATIENT DID NOT FUSE AND REVISION SURGERY WAS PERFORMED. THIS REPORT REPRESENTS THE BLOCKER.

  Patient problems: Injury

  MAUDE report 10083172 ↗
• InjuryMar 20, 2020Migration; Migration

  IT WAS REPORTED THAT A MANTIS REDUX BLOCKER MIGRATED POST-OPERATIVELY. THE PATIENT BEGAN TO HEAR NOISE AND EXPERIENCE PAIN 2 MONTHS AFTER INITIAL SURGERY. REVISION SURGERY WAS PERFORMED.

  Patient problems: Injury; Pain

  MAUDE report 9861800 ↗