MOJAVE Expandable Interbody System 7012-90095Recalls & reported problems
VB Spine LLC · Driver, Size 8 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888857391697), received between Apr 6, 2022 and Jul 15, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (5 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 18, 2026.
Most reported problems
Device problems
- Material Deformation5
- Fracture4
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2022Fracture; Material Deformation; Fracture; Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT TWO MOJAVE PL DRIVERS STRIPPED POST-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR THE FIRST OF THE TWO DRIVERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15029394 ↗MalfunctionJul 15, 2022Fracture; Material Deformation; Fracture; Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT TWO MOJAVE PL DRIVERS STRIPPED POST-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR THE SECOND OF THE TWO DRIVERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15029387 ↗MalfunctionMay 27, 2022Fracture; Material Deformation; Fracture; Material Deformation
IT WAS REPORTED THAT THE TIPS OF TWO MOJAVE PL DRIVERS SHEERED OFF INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE SECOND DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14523069 ↗MalfunctionMay 27, 2022Fracture; Material Deformation; Fracture; Material Deformation
IT WAS REPORTED THAT THE TIPS OF TWO MOJAVE PL DRIVERS SHEERED OFF INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE FIRST DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14523020 ↗MalfunctionApr 6, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TIP OF A MOJAVE DRIVER STRIPPED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR REPORTED SURGICAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14024645 ↗
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- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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