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CoRoent 6791715Recalls & reported problems

Nuvasive, Inc. · CoRoent® SI Screw, 4x15mm Self-Tap · Class 2 · Implant

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 00887517362421), received between Feb 16, 2018 and Jan 23, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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

  • Fracture2

Patient problems

  • Failure of Implant1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 23, 2020Fracture; Fracture

    ON (B)(6) 2016 PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY FUSION PROCEDURE AT C5-6 LEVELS. ON (B)(6) 2017 DURING FOLLOW UP, THE PATIENT WAS EXPERIENCING NECK AND SHOULDER PAIN. RADIOGRAPHS SHOWED NO HARDWARE FAILURE AND BONY IN-GROWTH AT C5-6. ON (B)(6) 2019 RADIOGRAPHS AND A CT SCAN SHOWED ONE OF THE SCREWS WAS BROKEN.

    Patient problems: Pain

    MAUDE report 9623147 ↗
  • MalfunctionFeb 16, 2018Fracture; Fracture

    ON (B)(6) 2015 PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C4-T1 LEVELS WITH INTERLOCK CAGES. ON (B)(6) 2016 POSTOPERATIVE FILMS INDICATED A SCREW FRACTURE AT C6 LEVEL. PATIENT IS ASYMPTOMATIC.

    Patient problems: Failure of Implant

    MAUDE report 7277274 ↗

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