MESA® Spinal System 801-05535Recalls & reported problems
VB Spine LLC · 801-05535 · 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 10888857135536), received between Jul 11, 2019 and Oct 29, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 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
Device problems
- Break2
- Migration1
- No Apparent Adverse Event1
Patient problems
- Pain3
- Injury2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2022Migration; Migration
A PATIENT WAS REVISED TO ADDRESS A MIGRATED MESA POLYAXIAL SCREW AT LEFT T12.
Patient problems: Pain
MAUDE report 15695035 ↗InjuryJul 12, 2019Break
A PATIENT THAT WAS ORIGINALLY OPERATED ON IN 2016, UNDERWENT REVISION SURGERY DUE TO THE PATIENT PRESENTING WITH PAIN. DURING SURGERY IT WAS NOTED THAT THE MESA POLYAXIAL SCREW WAS BROKEN.
Patient problems: Injury; Pain
MAUDE report 8787125 ↗InjuryJul 11, 2019No Apparent Adverse Event; Break; No Apparent Adverse Event
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE K2M MESA SYSTEM ON RIGHT SIDE, L4-L5, SINCE THE PATIENT PRESENTED WITH PAIN. DURING REMOVAL, THE SURGEON NOTED A SCREW WAS BROKEN.
Patient problems: Injury; No Patient Involvement; Pain
MAUDE report 8781871 ↗
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- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
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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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