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Brigade 8595535Recalls & reported problems

Nuvasive, Inc. · CoRoent® XLR-F Screw, 5.5x35mm · Class 2 · Implant

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 00887517323316), received between Sep 10, 2020 and Sep 10, 2020 — classified as 1 malfunction.

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 problems

  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • 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 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.