Brigade 8595520Recalls & reported problems
Nuvasive, Inc. · CoRoent® XLR-F Screw, 5.5x20mm · Class 2 · Implant
All models of Brigade (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517322951), received between Feb 17, 2021 and Feb 17, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Malposition of Device” (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.
Most reported problems
Device problems
- Malposition of Device1
Patient problems
- Pain1
- Swelling1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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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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