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CoRoent 6791712Recalls & reported problems

Nuvasive, Inc. · CoRoent® SI Screw, 4x12mm Self-Tap · 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 00887517362094), received between Aug 25, 2016 and Aug 25, 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

  • Neck Pain1

Recent adverse event reports

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

  • MalfunctionAug 25, 2016Fracture; Fracture

    A (B)(6) FEMALE UNDERWENT AN ACDF AT C4-7 SPINE LEVELS ON (B)(6) 2015. AT THREE-WEEK FOLLOW-UP, THE PATIENT REPORTED REDUCTION IN PAIN/RADICULOPATHY AND IMPROVED STRENGTH. APPROXIMATELY 17 MONTHS POSTOPERATIVELY PATIENT WAS EVALUATED FOR CERVICAL PAIN AND RADICULOPATHY AFTER HAVING FALLEN AS WELL AS LOWER BACK AND KNEE PAIN WHICH NECESSITATED TREATMENT WITH VICODIN. RADIOGRAPHS CONFIRMED SCREW FRACTURE AT C6-7. A REVISION SURGERY IS PLANNED FOR (B)(6) 2016. NO PATIENT INJURY WAS REPORTED.

    Patient problems: Neck Pain

    MAUDE report 5904081 ↗

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