MESA® Spinal System 801-36545MRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10888857140301), received between Nov 11, 2020 and Sep 8, 2023 — classified as 17 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Migration” (23 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2023Migration; Migration

  A PHYSICIAN REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A LOSS OF CORRECTION FOLLOWING MESA UNIPLANAR SCREW SLIPPAGE APPROXIMATELY SEVEN YEARS AFTER IMPLANTATION. PATIENT REPORTEDLY EXPERIENCED PAIN. FUSION WAS ACHIEVED AND THE CONSTRUCT WAS LENGTHENED TO L4.

  Patient problems: Pain

  MAUDE report 17715323 ↗
• InjuryJul 24, 2023Migration; Migration

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED FIVE DAYS AFTER IMPLANTATION TO ADDRESS A ROD MIGRATED FROM A MESA DEFORMITY UNIPLANAR SCREW. THE PATIENT REPORTED EXPERIENCING LOWER BACK PAIN.

  Patient problems: Pain

  MAUDE report 17376042 ↗
• MalfunctionJan 6, 2023Migration; Migration

  A COMPANY REPRESENTATIVE REPORTED AXIAL SLIPPAGE OF TWO MESA DEFORMITY, UNIPLANAR SCREWS APPROXIMATELY ONE YEAR POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND A REVISION SURGERY IS POSSIBLY NEEDED. THIS REPORT IS FOR THE SECOND OF THE TWO SCREWS.

  Patient problems: Pain

  MAUDE report 16116220 ↗
• MalfunctionJan 6, 2023Migration; Migration

  A COMPANY REPRESENTATIVE REPORTED AXIAL SLIPPAGE OF TWO MESA DEFORMITY, UNIPLANAR SCREWS APPROXIMATELY ONE YEAR POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND A REVISION SURGERY IS POSSIBLY NEEDED. THIS REPORT IS FOR THE FIRST OF THE TWO SCREWS.

  Patient problems: Pain

  MAUDE report 16116161 ↗
• MalfunctionDec 29, 2022Migration; Migration

  A COMPANY REPRESENTATIVE REPORTED AXIAL SLIPPAGE OF A MESA DEFORMITY SCREW APPROXIMATELY 26 MONTHS POST-OPERATIVELY. REVISION SURGERY IS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16072711 ↗
• InjuryOct 7, 2022Migration; Migration

  A PHYSICIAN REPORTED A MESA SCREW AXIAL SLIP APPROXIMATELY ONE-YEAR POST IMPLANT. THE PATIENT HAS BEEN REVISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15561947 ↗
• InjuryJul 26, 2022Migration; Migration

  A PHYSICIAN REPORTED AXIAL SLIPPAGE AT THE DISTAL END OF A CONSTRUCT ON BOTH THE RIGHT AND LEFT-SIDE. THE LEFT-SIDE L3 MESA DEFORMITY UNIPLANAR SCREW SHAFT ADDITIONALLY APPEARS TO BE EITHER FRACTURED OR DISENGAGED FROM THE TULIP. THE PATIENT IS BEING REVISED TO ADDRESS THE AXIAL SLIPPAGE. THIS REPORT CAPTURES THE RIGHT-SIDE MESA DEFORMITY UNIPLANAR SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108536 ↗
• MalfunctionJul 26, 2022Fracture; Fracture

  THE PATIENT WAS INITIALLY IMPLANTED T2 THROUGH L1. APPROXIMATELY TWO YEARS LATER THE PATIENT WAS REVISED TO ADDRESS PSEUDOARTHROSIS. THE RODS WERE CUT AT APPROXIMATELY THE LEVEL OF T11, ROD-TO-ROD CONNECTORS WERE PLACED ON THE CUT ENDS OF THE RODS, THE RIGHT-SIDE SCREW AT T11 WAS REMOVED, A NEW RIGHT-SIDE SCREW AT T12 WAS IMPLANTED, AND SHORT RODS WERE PLACED AT THE DISTAL END OF THE CONSTRUCT TO MAINTAIN THE ORIGINAL LENGTH OF T2 TO L1. THE X-RAYS PROVIDED BY THE HOSPITAL INDICATE THAT THE RIGHT-SIDE SCREWS AT T12 AND L1 AND THE LEFT-SIDE SCREW AT L1 WERE NOT REPLACED BUT WERE RE-SECURED. AN X-RAY PROVIDED FOR THREE MONTHS AFTER SURGERY APPEARS TO SHOW THE RIGHT-SIDE L3 SCREW FRACTURED. SIX MONTHS LATER, THE PATIENT WAS REVISED TO TREAT PERSISTENT PSEUDOARTHROSIS AND THE CONSTRUCT WAS EXTENDED DOWN TO L3. ADDITIONALLY, THE SCREW FRAGMENT AT RIGHT-SIDE L3 APPEARS TO HAVE BEEN REMOVED. AN X-RAY TAKEN FOUR DAYS AFTER SURGERY SHOWS A FRACTURED SCREW SHAFT IN THE LEFT-SIDE L1, HOWEVER, THE SCREW AT L1 IS INTACT SO THE FRACTURED SHAFT LIKELY BELONGS TO THE PREVIOUSLY IMPLANTED SCREW. THIS REPORT CAPTURES THE LEFT-SIDE MESA DEFORMITY UNIPLANAR SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108525 ↗
• InjuryJul 26, 2022Material Separation; Detachment of Device or Device Component; Migration; Material Separation; Detachment of Device or Device Component; Migration

  A PHYSICIAN REPORTED AXIAL SLIPPAGE AT THE DISTAL END OF A CONSTRUCT ON BOTH THE RIGHT AND LEFT-SIDE. THE LEFT-SIDE L3 MESA DEFORMITY UNIPLANAR SCREW SHAFT ADDITIONALLY APPEARS TO BE EITHER FRACTURED OR DISENGAGED FROM THE TULIP. THE PATIENT IS BEING REVISED TO ADDRESS THE AXIAL SLIPPAGE. THIS REPORT CAPTURES THE LEFT-SIDE MESA DEFORMITY UNIPLANAR SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108466 ↗
• MalfunctionJul 26, 2022Fracture; Fracture

  THE PATIENT WAS INITIALLY IMPLANTED T2 THROUGH L1. APPROXIMATELY TWO YEARS LATER THE PATIENT WAS REVISED TO ADDRESS PSEUDOARTHROSIS. THE RODS WERE CUT AT APPROXIMATELY THE LEVEL OF T11, ROD-TO-ROD CONNECTORS WERE PLACED ON THE CUT ENDS OF THE RODS, THE RIGHT-SIDE SCREW AT T11 WAS REMOVED, A NEW RIGHT-SIDE SCREW AT T12 WAS IMPLANTED, AND SHORT RODS WERE PLACED AT THE DISTAL END OF THE CONSTRUCT TO MAINTAIN THE ORIGINAL LENGTH OF T2 TO L1. THE X-RAYS PROVIDED BY THE HOSPITAL INDICATE THAT THE RIGHT-SIDE SCREWS AT T12 AND L1 AND THE LEFT-SIDE SCREW AT L1 WERE NOT REPLACED BUT WERE RE-SECURED. AN X-RAY PROVIDED FOR THREE MONTHS AFTER SURGERY APPEARS TO SHOW THE RIGHT-SIDE L3 SCREW FRACTURED. SIX MONTHS LATER, THE PATIENT WAS REVISED TO TREAT PERSISTENT PSEUDOARTHROSIS AND THE CONSTRUCT WAS EXTENDED DOWN TO L3. ADDITIONALLY, THE SCREW FRAGMENT AT RIGHT-SIDE L3 APPEARS TO HAVE BEEN REMOVED. AN X-RAY TAKEN FOUR DAYS AFTER SURGERY SHOWS A FRACTURED SCREW SHAFT IN THE LEFT-SIDE L1, HOWEVER, THE SCREW AT L1 IS INTACT SO THE FRACTURED SHAFT LIKELY BELONGS TO THE PREVIOUSLY IMPLANTED SCREW. THIS REPORT CAPTURES THE RIGHT-SIDE MESA DEFORMITY UNIPLANAR SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108328 ↗
• MalfunctionJul 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT EXPERIENCED FRACTURED MESA DEFORMITY UNIPLANAR SCREWS AT THE DISTAL END OF THE CONSTRUCT. THE EVENT WAS NOTED APPROXIMATELY ONE-YEAR POST-IMPLANTATION. REVISION SURGERY HAS NOT OCCURRED. THIS REPORT CAPTURES THE FIRST OF TWO FRACTURED SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988040 ↗
• MalfunctionJul 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT EXPERIENCED FRACTURED MESA DEFORMITY UNIPLANAR SCREWS AT THE DISTAL END OF THE CONSTRUCT. THE EVENT WAS NOTED APPROXIMATELY ONE-YEAR POST-IMPLANTATION. REVISION SURGERY HAS NOT OCCURRED. THIS REPORT CAPTURES THE SECOND OF TWO FRACTURED SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14987992 ↗
• InjuryMay 27, 2022Migration; Migration

  IT WAS REPORTED THAT A MESA UNIPLANAR SCREW SLIPPED AXIALLY POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED NOR PERFORMED AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14524956 ↗
• MalfunctionMay 26, 2022Migration; Migration

  IT WAS REPORTED VIA SURGEON THAT A MESA POLYAXIAL SCREW SLIPPED AXIALLY POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED NOR PREFORMED AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516871 ↗
• MalfunctionMay 26, 2022Migration; Migration

  IT WAS REPORTED VIA SURGEON THAT A MESA POLYAXIAL SCREW SLIPPED AXIALLY POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516811 ↗
• MalfunctionMay 5, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  A COMPANY REPRESENTATIVE REPORTED AN AXIAL SLIP OF A MESA DEFORMITY UNIPLANAR SCREW. REVISION SURGERY HAS NOT BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14292337 ↗
• MalfunctionMar 8, 2022Migration; Migration

  IT WAS REPORTED THAT A MESA UNIPLANAR SCREW EXPERIENCED AXIAL SLIPPAGE POST-OPERATIVELY. THIS LED TO LOSS OF CORRECTION IN THE PATIENT. IT IS NOT KNOWN AT THIS TIME IF REVISION SURGERY IS SCHEDULED OR WILL BE PERFORMED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690274 ↗
• InjuryMar 3, 2022Migration; Migration

  IT WAS REPORTED THAT A MESA UNIPLANAR SCREW EXPERIENCED AXIAL SLIPPAGE POST-OPERATIVELY. IT IS NOT KNOWN AT THIS TIME IF REVISION SURGERY IS SCHEDULED OR WILL BE PERFORMED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13662869 ↗
• InjuryDec 1, 2021Migration; Migration

  IT WAS REPORTED VIA CONTROL CT THAT A PATIENT EXPERIENCED A MESA SCREW AXIAL SLIP POST-OPERATIVELY. IT IS NOT KNOWN IF REVISION SURGERY HAS BEEN SCHEDULED OR PERFORMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910111 ↗
• MalfunctionNov 4, 2021Migration; Migration

  A PHYSICIAN REPORTED THAT A ROD HAS SLIPPED DOWN THE SCREWHEAD OF A MESA DEFORMITY UNIPLANAR SCREW. THE SECURING MECHANISM OF THE MESA SCREW IS DESIGNED TO RETAIN THE ROD AND KEEP IT IN PLACE. THE REPORTED EVENT IS ATTRIBUTABLE TO THE SCREW AS THE ROD CANNOT MIGRATE WHEN PROPERLY SECURED IN A ACCURATELY LOCKED SCREWHEAD. REVISION SURGERY HAS NEITHER BEEN PERFORMED OR SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750873 ↗
• InjuryAug 23, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A CONTROL X-RAY, A MESA DEFORMITY UNIPLANAR SCREW REVEALED SHAFT BREAKAGE. THE EVENT WILL REQUIRE REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356118 ↗
• MalfunctionAug 23, 2021Migration; Migration

  IT WAS REPORTED THAT DURING A CONTROL X-RAY, A MESA DEFORMITY UNIPLANAR SCREW REVEALED IT HAD SLIPPED AXIALLY ALONG ROD. THIS WILL REQUIRE REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354757 ↗
• InjuryApr 28, 2021Migration; Migration

  IT WAS REPORTED THAT A ROD SLIPPED THROUGH THE SCREWHEAD OF A MESA UNIPLANAR SCREW POST-OPERATIVELY. REVISION SURGERY IS NOW NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740927 ↗
• InjuryApr 13, 2021Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  IT WAS REPORTED THAT A ROD SLIPPED THROUGH A MESA UNIPLANAR SCREW THREE MONTH POST-OPERATIVELY. REVISION SURGERY IS NOW NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11658000 ↗
• InjuryApr 12, 2021Fracture; Fracture

  A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A ROD WHICH HAD "SLIPPED" THROUGH THE SCREWHEAD OF A MESA DEFORMITY UNIPLANAR SCREW. THE SECURING MECHANISM OF THE MESA SCREW IS DESIGNED TO RETAIN THE ROD AND KEEP IT IN PLACE. THE REPORTED EVENT IS ATTRIBUTABLE TO THE SCREW AS THE ROD CANNOT MIGRATE WHEN PROPERLY SECURED IN A ACCURATELY LOCKED SCREWHEAD. REVIEW OF THE X-RAY IMAGE PROVIDED SHOWS THAT A SECOND SCREW IN THE CONSTRUCT FRACTURED. THIS RECORD CAPTURES THE FRACTURED SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653838 ↗