BrigadeRecalls & reported problems across all models
Nuvasive, Inc. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 1
- Injuries reported
- 8
- Recalls
- 0
We found 17 models of Brigade by Nuvasive, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Dec 23, 2015 and Apr 17, 2025 — classified as 1 death, 8 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Brigade problems
Device problems
- Fracture8
- Adverse Event Without Identified Device or Use Problem7
- Migration or Expulsion of Device2
- Break1
- Malposition of Device1
- Migration1
- Patient-Device Incompatibility1
- Unintended Movement1
Patient problems
- Bacterial Infection4
- Failure of Implant4
- No Clinical Signs, Symptoms or Conditions3
- Pain3
- Laceration(s)2
- No Known Impact Or Consequence To Patient2
- Swelling2
- Abdominal Distention1
Brigade models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Brigade 7806535APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- Brigade 8594520SPINAL VERTEBRAL BODY REPLACEMENT DEVICE2 reports
- Brigade 6951434Intervertebral fusion device with bone graft, lumbar1 death2 reports
- Brigade 7880040APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Brigade 7881001ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Brigade 8594530SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- Brigade 8595520Intervertebral fusion device with bone graft, lumbar1 report
- Brigade 8595535SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- Brigade 6941238Intervertebral fusion device with bone graft, lumbar1 report
- Brigade 6941434SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- Brigade 6941438SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- Brigade 6951238SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- Brigade 6951438SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- Brigade 6971238Intervertebral fusion device with bone graft, lumbar1 report
- Brigade 7502104Intervertebral fusion device with integrated fixation, lumbar1 report
- Brigade 6965238Intervertebral fusion device with integrated fixation, lumbar1 report
- Brigade 6968439Intervertebral fusion device with integrated fixation, lumbar1 report
Recent Brigade adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2025Fracture; Fracture
THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE PMCF LUMBAR INTERBODY STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2023, A PATIENT UNDERWENT A ONE LEVEL ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE AT L5-S1 WITH TWO SELF FIXATING SCREWS. ON (B)(6) 2024 RADIOGRAPHS NOTED ONE OF THE ANTERIOR FIXATION SCREWS WAS BROKEN. ON (B)(6) 2024 THE PATIENT DEVELOPED WORSENING BACK PAIN AND RIGHT GREATER THAN LEFT LEG PAIN. NO TREATMENT HAS BEEN PROVIDED AND MONITORING WILL CONTINUE.
Patient problems: Pain
MAUDE report 21862227 ↗InjuryOct 20, 2024Migration; Migration
THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE PMCF INTERBODY STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2023 A PATIENT UNDERWENT A ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE AT L5/S1. NOTED ONLY TWO OF THE FOUR FIXATION SCREW PORTS WERE UTILIZED. ON (B)(6) 2024 THE PATIENT WAS EXPERIENCING LEFT ANKLE WEAKNESS AND FOOT DROP. CT SHOWED THE LEFT L5 SCREW ENCROACHING MEDIALLY INTO THE SPINAL CANAL. L5-S1 POSTERIOR REVISION DONE. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Muscle Weakness/Atrophy; Paralysis
MAUDE report 20489976 ↗InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024 A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE WITH POSTERIOR FIXATION. ON AN UNKNOWN DATE IT WAS FOUND THAT THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION. NO REVISION PROCEDURE WAS CONDUCTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Bacterial Infection
MAUDE report 20252722 ↗InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024 A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE WITH POSTERIOR FIXATION. ON AN UNKNOWN DATE IT WAS FOUND THAT THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION. A REVISION PROCEDURE WAS CONDUCTED ON (B)(6) 2024 AND THE INTERBODY WAS REPLACED WITH A NEW IMPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Bacterial Infection
MAUDE report 20252721 ↗InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024 A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE WITH POSTERIOR FIXATION. ON AN UNKNOWN DATE IT WAS FOUND THAT THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION. A REVISION PROCEDURE WAS CONDUCTED ON (B)(6) 2024 AND THE INTERBODY WAS REPLACED WITH A NEW IMPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Bacterial Infection
MAUDE report 20252433 ↗InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024 A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE WITH POSTERIOR FIXATION. ON AN UNKNOWN DATE IT WAS FOUND THAT THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION. A REVISION PROCEDURE WAS CONDUCTED ON (B)(6) 2024 AND THE INTERBODY WAS REPLACED WITH A NEW IMPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Bacterial Infection
MAUDE report 20252278 ↗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 ↗MalfunctionSep 14, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
THE PATIENT PRESENTED FOR L5/S1 ANTERIOR LUMBAR INTERBODY FUSION ON (B)(6) 2023. THE PATIENT DEMONSTRATED DEGENERATIVE DISC DISEASE AND A BILATERAL PARS DEFECT AT THE AND NORMATIVE BONE DENSITY AT THE INDEX LEVEL. THE PATIENT HAD A MODULUS ALIF CAGE, BRIGADE ALIF PLATE AND PLATE SCREWS IMPLANTED AT L5/S1. THE INDEX PROCEDURE WAS COMPLETED WITHOUT INCIDENT AS PER THE SURGICAL TECHNIQUE. UPON FURTHER EXAMINATION OF THE PATIENTS¿ 24 HOUR POST-OPERATIVE FILMS IT WAS EVIDENT THAT THE SCREWS HAD BECOME DISLODGED FROM THE VERTEBRAL BODIES AND THE MODULUS ALIF CAGE AND BRIGADE ALIF PLATE HAD MIGRATED ANTERIORLY. THE PATIENT WAS THEN BROUGHT BACK TO THEATRE ON (B)(6) 2023, FOR REVISION SURGERY. THE PLATE AND SCREWS WERE EXPLANTED AND THE INTERBODY CAGE WAS REPOSITIONED POSTERIORLY AND INSTRUMENTED WITH INTERFIXATED SCREWS, THE PATIENT WAS THEN REPOSITIONED IN THE PRONE POSITION AND POSTERIOR PEDICLE SCREW FIXATION OF L5/S1 WAS PERFORMED. THE REVISION SURGERY WAS COMPLETED WITHOUT INCIDENT AS PER SURGICAL TECHNIQUE. HOWEVER THE PATIENT COMPLAINED OF LEG PAIN POST-OPERATIVELY AS A RESULT OF THE FAILED CONSTRUCT, AND WAS GIVEN ADJUNCTIVE PAIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17746249 ↗MalfunctionJun 21, 2023Fracture; Fracture
IT WAS REPORTED THAT WHILE IMPACTING THE IMPLANT WITHIN THE DISC SPACE VIA INSERTER AND MALLET, THE IMPLANT FRACTURED. IT WAS REPORTED THAT PROPER SURGICAL TECHNIQUE WAS FOLLOWED. A NEW IMPLANT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE AND THERE WAS NO ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17176710 ↗InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON A CLINICAL STUDY THAT ON (B)(6) 2022 A PATIENT UNDERWENT A TRANSFORAMINAL INTERBODY FUSION. THE SURGEON IDENTIFIED A SMALL INCIDENTAL DUROTOMY THAT TOOK PLACE DURING SURGERY WHERE THE LIGAMENTUM HAD ADHERED TO THE DURA. A DURAGEN PATCH WAS PLACED AND COVERED WITH ADHERUS. THERE WAS NO EXTRAVASATION AFTER THE REPAIR.
Patient problems: Laceration(s)
MAUDE report 15810321 ↗MalfunctionFeb 17, 2021Malposition of Device
ON (B)(6) 2019 A PATIENT UNDERWENT SPINAL SURGERY ON L3-S1. ON (B)(6) 2019 THE PATIENT REPORTED INCREASED TAILBONE/RIGHT HIP AREA PAIN. THE PATIENT STATED THEIR MAJOR COMPLAINT IS PAIN IN THE RIGHT HIP REGION AND IN THEIR RIGHT BUTTOCKS REGION. THE PAIN RADIATED INTO BILATERAL LEGS, BUT IS WORSE ON THE RIGHT SIDE. ON (B)(6) 2020 THE PATIENT WAS TREATED WITH BILATERAL SI JOINT INJECTION. THE SURGEON REPORTED THE POSSIBILITY OF THE PAIN COULD BE CAUSED BY THE RIGHT S2 ALAR SCREW.
Patient problems: Pain; Swelling
MAUDE report 11339828 ↗InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON TUESDAY, (B)(6) 2020, A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION, AND SUFFERED A SEIZER IN THE RECOVERY ROOM. THE FOLLOWING DAY THE PATIENT STARTED EXPERIENCING BLOATING, INTENSE VOMITING AND NAUSEA. AS A RESULT THE PATIENT WAS NOT RELEASED FROM THE HOSPITAL FOR THREE DAYS. AFTER BEING RELEASED FROM THE HOSPITAL THE PATIENT BEGAN TO EXPERIENCE PAIN, A DISTENDED STOMACH, SWELLING OF HER LEG JOINTS, AS WELL AS INTERMITTENT RIGHT LEG COLLAPSE. THE ISSUES HAVE LED TO MULTIPLE ER VISITS.
Patient problems: Abdominal Distention; Nausea; Seizures; Swelling; Vomiting
MAUDE report 10826524 ↗MalfunctionSep 10, 2020Fracture; Fracture
ON (B)(6) 2019 A PATIENT UNDERWENT SPINAL PROCEDURE AT L3/S1 LEVELS. ON (B)(6) 2019, THE PATIENT REPORTED CATCHING HER PARENT WHO WAS ABOUT TO FALL. PATIENT STARTED EXPERIENCING BACK PAIN, AN MRI WAS TAKEN AND INDICATED THE IMPLANTS WERE IN GOOD POSITION. ON (B)(6) 2020, THE PATIENT WAS SEEN FOR A POSTOPERATIVE VISIT IN WHICH RADIOGRAPHS INDICATED A SCREW WAS FOUND TO BE BROKEN AT THE L5 LEVEL. THERE IS NO PLAN FOR REVISION PROCEDURE AT THIS TIME.
Patient problems: Pain
MAUDE report 10519073 ↗InjuryDec 20, 2019Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device
ADDITIONAL INFORMATION RECEIVED FROM PATIENT STATING PATIENT WAS EXPERIENCING PAIN AND UNDERWENT A RECONSTRUCTIVE PROCEDURE AT L4 AND L5, S1 WHERE THE BONE GROWTH MATERIAL DID NOT TAKE. IT IS UNKNOWN WHEN THE REVISION PROCEDURE OCCURRED.
Patient problems: Failure of Implant
MAUDE report 9505453 ↗MalfunctionNov 5, 2018Fracture; Fracture
ON AN UNKNOWN DATE A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE AT L5-S1 LEVELS. POST-OPERATIVE RADIOGRAPHS SHOWED A SCREW FRACTURE AT S1 LEVEL. THE PATIENT WAS FUSED AND HAS IS ASYMPTOMATIC. NO REVISION PROCEDURE IS PLANNED AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8040373 ↗
Other Nuvasive, Inc. products
All Nuvasive, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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