MESA® Spinal System 801-35535Recalls & reported problems
VB Spine LLC · Uniplanar Screw Size Ø5.5x35 mm · Class 2 · Implant
All models of MESA Spinal System (55)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857139824), received between Nov 27, 2019 and Nov 27, 2019 — classified as 3 injuries.
The most frequently reported specific device problem is “Positioning Problem” (1 report).
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
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Positioning Problem1
Patient problems
- Neurological Deficit/Dysfunction3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT SUFFERED FROM TEMPORARY NEURO-MONITORING LOSS FOLLOWING THE INSERTION OF THE RIGHT SIDE MESA UNIPLANAR SCREWS. THE SCREWS WERE REPLACED AND RE-POSITIONED, WHEREAS THE PATIENT REGAINED SENSORY-EVOKED POTENTIALS. THIS REPORT CAPTURES THE FIRST OF 3 SCREWS.
Patient problems: Neurological Deficit/Dysfunction
MAUDE report 9384417 ↗InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem
IT WAS REPORTED THAT A PATIENT SUFFERED FROM TEMPORARY NEURO-MONITORING LOSS FOLLOWING THE INSERTION OF THE RIGHT SIDE MESA UNIPLANAR SCREWS. THE SCREWS WERE REPLACED AND RE-POSITIONED, WHEREAS THE PATIENT REGAINED SENSORY- EVOKED POTENTIALS. THIS REPORT CAPTURES THE THIRD OF 3 SCREWS.
Patient problems: Neurological Deficit/Dysfunction
MAUDE report 9384410 ↗InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT SUFFERED FROM TEMPORARY NEURO-MONITORING LOSS FOLLOWING THE INSERTION OF THE RIGHT SIDE MESA UNIPLANAR SCREWS. THE SCREWS WERE REPLACED AND RE-POSITIONED, WHEREAS THE PATIENT REGAINED SENSORY- EVOKED POTENTIALS. THIS REPORT CAPTURES THE SECOND OF THREE SCREWS.
Patient problems: Neurological Deficit/Dysfunction
MAUDE report 9384135 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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