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Brigade 8594530Recalls & reported problems

Nuvasive, Inc. · CoRoent® XLR-F Screw, 4.5x30mm · 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 00887517322920), received between Aug 20, 2016 and Aug 20, 2016 — 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

  • Failure of Implant1
  • Osteolysis1

Recent adverse event reports

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

  • MalfunctionAug 20, 2016Fracture; Fracture

    ON (B)(6) 2016, (B)(6) MALE PATIENT UNDERWENT AN ALIF PROCEDURE AT L5-S1. ON (B)(6) 2016, A POST-OPERATIVE INTERBODY DEVICE SCREW FRACTURE WAS REPORTED AT THE L5 DISC SPACE. PATIENT UNDERWENT ADDITIONAL SURGICAL PROCEDURE TO TREAT OSTEOLYSIS ON (B)(6) 2016, DURING WHICH TIME, THE FRACTURED SCREW WAS REMOVED SUCCESSFULLY. NO PATIENT INJURY REPORTED.

    Patient problems: Failure of Implant; Osteolysis

    MAUDE report 5892481 ↗

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