MESA Small Stature Spinal SystemRecalls & reported problems across all models
VB Spine LLC · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 0
We found 16 models of MESA Small Stature Spinal System by VB Spine LLC in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Mar 17, 2016 and May 20, 2022 — classified as 15 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Migration” (12 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
Most reported MESA Small Stature Spinal System problems
Device problems
- Migration12
- Fracture8
- Break3
- Detachment of Device or Device Component3
- Material Separation3
- Unintended Movement2
- Device Dislodged or Dislocated1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Information6
- No Consequences Or Impact To Patient5
- Injury3
- Neck Pain1
- Pain1
MESA Small Stature Spinal System models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MESA® Small Stature Spinal System 3001-04030APPLIANCE, FIXATION, SPINAL INTERLAMINAL6 reports
- MESA® Small Stature Spinal System 3001-05535ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- MESA® Small Stature Spinal System 3001-04540Orthosis, spondylolisthesis spinal fixation2 reports
- MESA® Small Stature Spinal System 3001-35530Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- MESA® Small Stature Spinal System 3001-35540ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- MESA® Small Stature Spinal System 3001-05550Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- MESA® Small Stature Spinal System 3001-06535Orthosis, spondylolisthesis spinal fixation1 report
- MESA® Small Stature Spinal System 3001-06555Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- MESA® Small Stature Spinal System 3001-06575Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- MESA® Small Stature Spinal System 3001-07560APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- MESA® Small Stature Spinal System 3001-07565APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- MESA® Small Stature Spinal System 3001-36540Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- MESA® Small Stature Spinal System 3001-84545NORTHOSIS, SPINAL PEDICLE FIXATION1 report
- MESA® Small Stature Spinal System 3001-84560GORTHOSIS, SPINAL PEDICLE FIXATION1 report
- MESA® Small Stature Spinal System 3001-H45500TOrthosis, spondylolisthesis spinal fixation1 report
- MESA® Small Stature Spinal System 3011-64595APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
Recent MESA Small Stature Spinal System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A SCHEDULED EXTENSION SURGERY, A MESA SM STATURE POLYAXIAL SCREW WAS DISCOVERED TO BE FRACTURED. THE SCREW WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 15 MINUTE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14462292 ↗InjuryJan 5, 2022Migration; Migration
IT WAS REPORTED THAT SLIPPAGE OF THE ROD OCCURRED ON FOUR MESA POLYAXIAL SCREWS AT L4-L5 AND L5-S1 POST-OPERATIVELY. REVISION HAS OCCURRED. THIS REPORT WILL CAPTURE THE SECOND OF FOUR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13172575 ↗InjuryJan 5, 2022Migration; Migration
IT WAS REPORTED THAT SLIPPAGE OF THE ROD OCCURRED ON FOUR MESA POLYAXIAL SCREWS AT L4-L5 AND L5-S1 POST-OPERATIVELY. REVISION HAS OCCURRED. THIS REPORT WILL CAPTURE THE FOURTH OF FOUR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13172555 ↗InjuryJan 5, 2022Migration; Migration
IT WAS REPORTED THAT SLIPPAGE OF THE ROD OCCURRED ON FOUR MESA POLYAXIAL SCREWS AT L4-L5 AND L5-S1 POST-OPERATIVELY. REVISION HAS OCCURRED. THIS REPORT WILL CAPTURE THE THIRD OF FOUR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13172548 ↗InjuryJan 5, 2022Migration; Migration
IT WAS REPORTED THAT SLIPPAGE OF THE ROD OCCURRED ON FOUR MESA POLYAXIAL SCREWS AT L4-L5 AND L5-S1 POST-OPERATIVELY. REVISION HAS OCCURRED. THIS REPORT WILL CAPTURE THE FIRST OF FOUR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13172531 ↗InjuryDec 17, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT THE 'HEAD' OF A MESA SM STATURE DEFORMITY POLYAXIAL SCREW 'POPPED OFF' POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED TO REPLACE THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13025338 ↗MalfunctionOct 22, 2021Migration; Migration
IT WAS REPORTED THAT THE MESA SMALL STATURE SPINAL SYSTEM DEFORMITY POLYAXIAL SCREW EXPERIENCED AXIAL SLIPPAGE OF THE ROD AT L5 POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12683938 ↗MalfunctionAug 24, 2021Migration; Migration
IT WAS REPORTED THAT MESA RAIL RODS SLIPPED FROM MESA UNIPLANAR SCREWS AT T3 POST-OPERATIVELY. PLANS FOR REVISION SURGERY ARE NOT KNOWN AT THIS TIME. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS RECORD CAPTURES THE SECOND OF THE TWO MESA UNIPLANAR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12360360 ↗MalfunctionAug 24, 2021Migration; Migration
IT WAS REPORTED THAT MESA RAIL RODS SLIPPED FROM MESA UNIPLANAR SCREWS AT T3 POST-OPERATIVELY. PLANS FOR REVISION SURGERY ARE NOT KNOWN AT THIS TIME. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS RECORD CAPTURES THE FIRST OF THE TWO MESA UNIPLANAR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12360354 ↗InjuryAug 10, 2021Migration; Migration
IT WAS REPORTED VIA CLINICAL STUDY THAT A PATIENT EXPERIENCED BACK AND NECK PAIN APPROXIMATELY 1 YEAR AFTER THEIR INDEX SURGERY. THIS WAS INITIALLY REPORTED IN RELATION TO A CASCADIA CAGE REPORTED VIA MRN 3004774118-2020-00081. ADDITIONAL INFORMATION RECEIVED ON 7/22/2021 INDICATED THERE WAS NO COMPLAINT AGAINST THIS CASCADIA CAGE AND IT WAS IN FACT TWO MESA SCREWS THAT HAD MIGRATED. IT WAS NOTED THAT A ROD HAD DISCONNECTED FROM A MESA SCREW AT RIGHT L5. THE PATIENT WAS REVISED AND IT WAS DISCOVERED AT THIS TIME THAT THE SCREW AT LEFT L6 WAS ALSO LOOSE. THE TWO PEDICLE SCREWS, AT RIGHT L5 AND LEFT L6, WERE THEN REMOVED AND REPLACED. THIS REPORT CAPTURES THE MIGRATED SCREW AT RIGHT L5.
Patient problems: Neck Pain; Pain
MAUDE report 12304860 ↗MalfunctionJan 21, 2021Material Deformation; Migration; Material Deformation; Migration
IT WAS REPORTED THAT DURING A SCHEDULED REVISION SURGERY TO EXTEND THE CONSTRUCT, THE MESA PARALLEL ROD CONNECTOR WAS OBSERVED TO BE "LOOSE." THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER CONNECTOR. UPON EXPLANTATION, THE "NUTS" WERE FOUND TO BE "DEFORMED." NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11207555 ↗InjuryOct 1, 2020Fracture; Material Separation; Fracture; Material Separation
A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO REPLACE A FRACTURED MESA POLYAXIAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10616912 ↗MalfunctionJul 31, 2020Fracture; Fracture
IT WAS REPORTED THAT THE INNER COLLET OF 3 MESA SM STATURE DEFORMITY POLYAXIAL SCREWS BROKE DURING REDUCTION OF THE RAIL INTRA-OPERATIVELY. THE SCREWS WERE REMOVED AND REPLACED. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 5 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL REPRESENT THE SECOND OF THREE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10353178 ↗MalfunctionJul 31, 2020Fracture; Material Separation; Fracture; Material Separation
IT WAS REPORTED THAT THE INNER COLLET OF 3 MESA SM STATURE DEFORMITY POLYAXIAL SCREWS BROKE DURING REDUCTION OF THE RAIL INTRA-OPERATIVELY. THE SCREWS WERE REMOVED AND REPLACED. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 5 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL REPRESENT THE FIRST OF THREE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10353173 ↗MalfunctionJul 31, 2020Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event
IT WAS REPORTED THAT THE INNER COLLET OF 3 MESA SM STATURE DEFORMITY POLYAXIAL SCREWS BROKE DURING REDUCTION OF THE RAIL INTRA-OPERATIVELY. THE SCREWS WERE REMOVED AND REPLACED. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 5 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL REPRESENT THE THIRD OF THREE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10353172 ↗
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
- MESA Spinal System55 models · 140 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
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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