Gradient 7450716Recalls & reported problems
Nuvasive, Inc. · Gradient Screw, 4.5x16mm Fixed · Class 2 · Implant
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 00887517482143), received between Feb 24, 2017 and Feb 24, 2017 — 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.
MalfunctionFeb 24, 2017Fracture; Fracture
ON (B)(6) 2013 A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A 4 LEVEL PROCEDURE FROM C4 TO T1 SPINE LEVELS. THE 12-MONTH FOLLOW-UP NOTES INDICATE FRACTURE OF TWO SCREWS AT THE T1 LEVEL. THE FRACTURED SCREWS REMAIN IN THE PATIENT. NO REVISION IS PLANNED. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 6358374 ↗
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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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