MOJAVE Expandable Interbody System 7012-10001Recalls & reported problems
VB Spine LLC · Locking Screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857327146), received between Mar 14, 2022 and Mar 14, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (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 18, 2026.
Most reported problems
Device problems
- Difficult to Advance2
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2022Difficult to Advance; Insufficient Device Problem Information; Difficult to Advance; Insufficient Device Problem Information
A COMPANY REPRESENTATIVE REPORTED THAT, DURING IMPLANTATION OF A MOJAVE PL EXPANDABLE INTERBODY AND TWO MOJAVE PL LOCKING SCREWS, THE, "IMPLANT CONTINUES TO ADVANCE THROUGH ITS STOP UPON INSERTION." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO MOJAVE PL LOCKING SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13763312 ↗MalfunctionMar 14, 2022Difficult to Advance; Insufficient Device Problem Information; Difficult to Advance; Insufficient Device Problem Information
A COMPANY REPRESENTATIVE REPORTED THAT, DURING IMPLANTATION OF A MOJAVE PL EXPANDABLE INTERBODY AND TWO MOJAVE PL LOCKING SCREWS, THE, "IMPLANT CONTINUES TO ADVANCE THROUGH ITS STOP UPON INSERTION." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO MOJAVE PL LOCKING SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13763311 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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