Brigade 8594520Recalls & reported problems
Nuvasive, Inc. · CoRoent® XLR-F Screw, 4.5x20mm · Class 2 · Implant
Data updated Oct 13, 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 00887517322685), received between Sep 22, 2017 and Oct 18, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture1
- Patient-Device Incompatibility1
- Unintended Movement1
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2017Fracture; Fracture
ON (B)(6) 2015 A PATIENT UNDERWENT AN INTERBODY PLACEMENT PROCEDURE AT L5/S1 LEVELS WITH NO REPORTED PROBLEMS. POST-SURGERY FOLLOW UPS INDICATED TWO FRACTURED FIXATION SCREWS AND A HORIZONTAL DIVIDE WITHIN THE INTERBODY. NO REVISION SURGERY HAS BEEN REPORTED NOR PATIENT INJURY.
Patient problems: Failure of Implant
MAUDE report 6958964 ↗MalfunctionSep 22, 2017Patient-Device Incompatibility; Unintended Movement; Patient-Device Incompatibility; Unintended Movement
PATIENT REPORTED A POTENTIAL METAL SENSITIVITY FOLLOWING IMPLANTATION OF A SINGLE-LEVEL BRIGADE INTERBODY DEVICE WITH COROENT XLR-F SCREWS. AS PER PATIENT ON (B)(6) 2016, A FOLLOW UP VISIT NOTED LOOSENING OF SCREWS WITH INDICATION OF FUSION. PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2017 WHERE SUPPLEMENTAL FIXATION WAS DESCRIBED.
Patient problems: Failure of Implant
MAUDE report 6886270 ↗
Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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