Brigade 6951434Recalls & reported problems
Nuvasive, Inc. · Brigade Implant, 14x34x24mm 12° · Class 2 · Implant
All models of Brigade (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517400420), received between Dec 23, 2015 and Jul 12, 2024 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Death1
- Laceration(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2024Break; Break
IT WAS REPORTED THAT WHEN INSERTING AN INTERVERTEBRAL SPACER DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE, THE INSERTER LOCKED AND WOULD NOT DISENGAGE FROM THE IMPLANT WHICH CAUSED THE SPACER TO BREAK. NO FURTHER INFORMATION ON PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19733539 ↗DeathDec 23, 2015Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2015, DURING AN ANTERIOR RETRACTOR PLACEMENT AT L4-5 THE PATIENT SUFFERED A MORTAL LACERATION OF A VESSEL AND EXPIRED INTRAOPERATIVELY. THE LACERATION REPORTEDLY OCCURRED DURING THE EARLY PART OF THE PROCEDURE WHEN ATTEMPTING TO ACCESS THE SPINAL COLUMN.
Patient problems: Death; Laceration(s)
MAUDE report 5324786 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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