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CoRoent 1903016Recalls & reported problems

Nuvasive, Inc. · Interlock II Screw, 4.0x16mm Self-Tap · Class 2 · Implant

All models of CoRoent (64)

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 00887517945747), received between Aug 26, 2020 and Aug 26, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • MalfunctionAug 26, 2020Fracture; Fracture

    ON (B)(6) 2020 A PATIENT UNDERWENT A SPINAL PROCEDURE. AS PER REPORTER APPROXIMATELY, FIVE MONTHS POST-OPERATIVE THE SURGEON REPORTED THAT AN INTERLOCK SCREW HAD FRACTURED. NO PATIENT INJURY REPORTED AND NO REVISION SURGERY IS PLANNED.

    Patient problems: Failure of Implant

    MAUDE report 10457762 ↗

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Sources and updates

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