NuVasive 5450065Recalls & reported problems
Nuvasive, Inc. · Universal Screwdriver, CoRoent XL-F · Class 1
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 00887517247988), received between Aug 26, 2022 and Aug 26, 2022 — 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
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2022Fracture; Fracture
DURING AN L3 TO L4 EXTREME LUMBAR INTERBODY FUSION PROCEDURE ON 02 AUGUST 2022 THE SURGEON NOTICED THAT THE TIP OF THEIR DRIVER FRACTURED AND WAS LODGED INTO THE HEAD OF AN IMPLANTED SCREW AND COULD NOT BE RETRIEVED. THE SURGEON OPTED NOT TO ATTEMPT A RETRIEVAL OF THE FRAGMENT AS THEY THOUGHT IT WOULD NOT BE POSSIBLE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 15306569 ↗
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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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