CoRoent 1903014Recalls & reported problems
Nuvasive, Inc. · Interlock II Screw, 4.0x14mm Self-Tap · Class 2 · Implant
All models of CoRoent (64)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00887517945723), received between Feb 12, 2021 and Aug 11, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture2
Patient problems
- Headache1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2023Fracture; Fracture
ON (B)(6) 2022 A PATIENT UNDERWENT A SPINAL PROCEDURE. ON (B)(6) 2023 IT WAS DISCOVERED THERE WAS A BROKEN SCREW. NO PATIENT INJURIES REPORTED. NO REVISION SURGERY SCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17513735 ↗MalfunctionFeb 12, 2021Fracture; Fracture
ON (B)(6) 2020 A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE AT UNKNOWN LEVELS OF THE SPINE. THE PATIENT WAS COMPLAINING OF PAIN AND DISCOMFORT TO HER LOCAL PEDIATRIC NEUROSURGEON IN HOUSTON AND WAS EXPERIENCING DISCOMFORT AND HEADACHES. ON A UNKNOWN DATE IT WAS DISCOVERED THAT AN IMPLANTED CERVICAL SCREW HAD FRACTURED POST-OP.
Patient problems: Headache; Pain
MAUDE report 11322663 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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