MESA Spinal SystemRecalls & reported problems across all models
VB Spine LLC · 55 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 140
- Deaths reported
- 0
- Injuries reported
- 73
- Recalls
- 0
We found 55 models of MESA Spinal System by VB Spine LLC in the FDA's device registry (GUDID). Together they are named in 140 adverse event reports in the FDA's MAUDE database, received between Sep 30, 2015 and Sep 10, 2026 — classified as 73 injuries, 67 malfunctions.
The most frequently reported specific device problem is “Migration” (55 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MESA Spinal System problems
Device problems
- Migration55
- Fracture50
- Break9
- Material Deformation8
- Adverse Event Without Identified Device or Use Problem7
- Mechanical Jam7
- Insufficient Device Problem Information6
- Device Dislodged or Dislocated4
Patient problems
- No Clinical Signs, Symptoms or Conditions78
- Pain24
- Injury15
- No Information11
- No Consequences Or Impact To Patient10
- Insufficient Information8
- Discomfort4
- Neurological Deficit/Dysfunction3
MESA Spinal System models
55 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MESA® Spinal System 801-36545MAPPLIANCE, FIXATION, SPINAL INTERLAMINAL30 reports
- MESA Spinal System 6201-90084Orthopedic manual surgical instrument9 reports
- MESA® Spinal System 801-06545Orthosis, spinal pedicle fixation, for degenerative disc disease7 reports
- MESA® Spinal System 801-06540APPLIANCE, FIXATION, SPINAL INTERLAMINAL6 reports
- MESA® Spinal System 801-36540MOrthosis, spinal pedicle fixation, for degenerative disc disease5 reports
- MESA® Spinal System 6201-05535Pedicle screw spinal system, adolescent idiopathic scoliosis4 reports
- MESA® Spinal System 801-05535Orthosis, spinal pedicle fixation, for degenerative disc disease3 reports
- MESA® Spinal System 801-05540APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- MESA® Spinal System 801-07540Orthosis, spondylolisthesis spinal fixation3 reports
- MESA® Spinal System 801-35535APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- MESA® Spinal System 801-37550MORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- MESA Spinal System 801-90066Orthopedic manual surgical instrument3 reports
- MESA Spinal System 801-90143Orthopedic manual surgical instrument3 reports
- MESA Spinal System 801-90147Orthopedic manual surgical instrument3 reports
- MESA® Spinal System 6201-36540Orthosis, spinal pedicle fixation, for degenerative disc disease3 reports
- MESA® Spinal System 801-06540DOrthosis, spondylolisthesis spinal fixation2 reports
- MESA® Spinal System 801-06550Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- MESA® Spinal System 801-07540DAPPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- MESA® Spinal System 801-35530APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- MESA® Spinal System 801-35540Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- MESA® Spinal System 801-35540MPedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- MESA® Spinal System 801-H55495APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- MESA® Spinal System 6201-04040Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- MESA® Spinal System 6201-06540Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- MESA® Spinal System 6201-08570APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- MESA® Spinal System 6201-35535Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- MESA Spinal System 6201-90050Orthopedic manual surgical instrument2 reports
- MESA Spinal System 6201-90001Orthopedic manual surgical instrument1 report
- MESA® Spinal System 801-05535DAPPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- MESA® Spinal System 801-05540DORTHOSIS, SPINAL PEDICLE FIXATION1 report
- MESA® Spinal System 801-05545ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- MESA® Spinal System 801-05545DOrthosis, spondylolisthesis spinal fixation1 report
- MESA® Spinal System 801-06545DAPPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- MESA® Spinal System 801-07545Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- MESA® Spinal System 801-07550Orthosis, spondylolisthesis spinal fixation1 report
- MESA® Spinal System 801-07550DOrthosis, spondylolisthesis spinal fixation1 report
- MESA® Spinal System 801-07560ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- MESA® Spinal System 801-35540M-SGAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- MESA® Spinal System 801-36530MORTHOSIS, SPINAL PEDICLE FIXATION1 report
- MESA® Spinal System 801-37545MOrthosis, spinal pedicle fixation, for degenerative disc disease1 report
- MESA® Spinal System 801-74050Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- MESA® Spinal System 801-81002HOrthosis, spinal pedicle fixation, for degenerative disc disease1 report
- MESA Spinal System 801-90038Orthopedic manual surgical instrument1 report
- MESA Spinal System 801-90097Orthopedic manual surgical instrument1 report
- MESA® Spinal System 811-H55495Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- MESA® Spinal System 811-H655495Orthosis, spondylolisthesis spinal fixation1 report
- MESA® Spinal System 6201-04530Orthosis, spondylolisthesis spinal fixation1 report
- MESA® Spinal System 6201-06545Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- MESA® Spinal System 6201-06550APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- MESA® Spinal System 6201-07580Orthosis, spondylolisthesis spinal fixation1 report
- MESA® Spinal System 6201-36545APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- MESA® Spinal System 6201-05530-G1APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- MESA® Spinal System 6201-06540-G1APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- MESA® Spinal System 6201-06550-G1Orthosis, spondylolisthesis spinal fixation1 report
- MESA Spinal System 6201-90085Orthopedic manual surgical instrument1 report
Recent MESA Spinal System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Fracture
A company representative reported that the tip of a Mesa Jack Cricket fractured intra-operatively and that the fractured tip remains in the patient. The procedure was completed successfully with a 10 minute surgical delay and no adverse consequence to the patient. On (b)(6) 2026, an additional fractured Mesa Cricket was returned and the fractured tip may have also remained in the patient. This report captures the second returned Mesa Cricket.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716455 ↗MalfunctionJun 29, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A MESA JACK CRICKET FRACTURED INTRA-OPERATIVELY AND THAT THE FRACTURED TIP REMAINS IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659921 ↗InjurySep 29, 2025Migration; Migration
IT WAS REPORTED THAT A MESA UNIPLANAR SCREW MIGRATED POST-OPERATIVELY AND THAT THE PATIENT DEVELOPED AN "UNBALANCED CONDITION". THE PATIENT WAS REVISED.
Patient problems: Insufficient Information
MAUDE report 23166657 ↗MalfunctionJul 10, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Migration; Detachment of Device or Device Component; Device Dislodged or Dislocated; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469306 ↗InjuryApr 15, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 1 YEAR AND 10 MONTHS POST-OPERATIVELY TO ADDRESS TWO FRACTURED MESA POLYAXIAL SCREWS. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.
Patient problems: Discomfort; Insufficient Information; Pain
MAUDE report 21838702 ↗InjuryApr 15, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 1 YEAR AND 10 MONTHS POST-OPERATIVELY TO ADDRESS TWO FRACTURED MESA POLYAXIAL SCREWS. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.
Patient problems: Discomfort; Insufficient Information; Pain
MAUDE report 21838684 ↗MalfunctionOct 24, 2024Unstable; Unstable
IT WAS REPORTED THAT A MESA 2 POLYAXIAL SCREW DID NOT FINAL LOCK PROPERLY INTRA-OPERATIVELY, AND THAT THE ROD WAS ABLE TO ROTATE SLIGHTLY IN THE SCREW HEAD AFTER FINAL LOCKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. IT WAS FURTHER REPORTED THAT THE SURGEON WAS NOT SATISFIED WITH THE CORRECTION ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20529343 ↗MalfunctionJul 1, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A MESA 2 SCREW INSERTER FRACTURED DURING SURGERY. THE FRACTURED TIP WAS NOT LOCATED POST-OPERATIVELY AND THE OPERATING SURGEON WAS, "CONFIDENT THAT THE TIP DID NOT FALL INTO THE PATIENT." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19652179 ↗InjuryMay 22, 2024Unintended Movement; Insufficient Device Problem Information; Unintended Movement; Insufficient Device Problem Information
A COMPANY REPRESENTATIVE REPORTED THAT, DURING A SCOLIOSIS CORRECTION, A MESA LAMINAR HOOK ENTERED THE PATIENT'S SPINAL CANAL. NEUROMONITORING WAS TEMPORARILY LOST AND THE PATIENT WAS WOKEN UP MID-SURGERY TO TEST FOOT MOBILITY. ALL OF THE IMPLANTS WERE REMOVED AND THE PATIENT WAS REPORTED TO BE MOBILE AFTER THE SURGERY.
Patient problems: Spinal Cord Injury
MAUDE report 19371212 ↗InjuryNov 17, 2023Migration; Migration
IT WAS REPORTED THAT A SCOLIOSIS PATIENT WAS REVISED TO ADDRESS POST-OPERATIVE MESA DEFORMITY POLYAXIAL SCREW MIGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18160127 ↗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 ↗InjuryMar 1, 2023Fracture; Fracture
A PATIENT WAS REVISED TO ADDRESS A FRACTURED MESA DEFORMITY SCREW AT RIGHT-SIDE L5 AND A LEFT-SIDE L5 MESA DEFORMITY SCREW WHICH WAS "LOOSE IN THE BONE." THE PATIENT REPORTED EXPERIENCING "PROGRESSIVELY MORE PAIN" APPROXIMATELY TWO-MONTHS POST-OPERATIVELY. THIS REPORT CAPTURED THE FRACTURED, RIGHT-SIDE SCREW.
Patient problems: Pain
MAUDE report 16464320 ↗InjuryMar 1, 2023Migration; Migration
A PATIENT WAS REVISED TO ADDRESS A FRACTURED EVEREST DEFORMITY SCREW AT RIGHT-SIDE L5 AND A LEFT-SIDE L5 EVEREST DEFORMITY SCREW WHICH WAS "LOOSE IN THE BONE." THE PATIENT REPORTED EXPERIENCING "PROGRESSIVELY MORE PAIN" APPROXIMATELY TWO-MONTHS POST-OPERATIVELY. THIS REPORT CAPTURED THE MIGRATED, LEFT-SIDE SCREW.
Patient problems: Pain
MAUDE report 16464318 ↗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 ↗
Other VB Spine LLC products
- EVEREST Spinal System77 models · 336 reports · 3 recalls
- YUKON OCT Spinal System54 models · 238 reports · 3 recalls
- OZARK Cervical Plate System54 models · 270 reports
- ALEUTIAN Interbody Systems37 models · 135 reports
- CHESAPEAKE Stabilization System31 models · 46 reports · 1 recall
- PYRENEES Cervical Plate System29 models · 96 reports
- DENALI Spinal System22 models · 80 reports
- CASCADIA Interbody System28 models · 65 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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