Gradient 7460612Recalls & reported problems
Nuvasive, Inc. · Gradient Screw, 4.0x12mm · 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 00887517487223), received between Feb 22, 2017 and Feb 22, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
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 22, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2014 A (B)(6) YEAR OLD MALE PATIENT HAD 4 LEVEL PROCEDURE FROM C3 TO C7. DURING THE 12 MONTH FOLLOW UP IT WAS DISCOVERED VIA RADIOGRAPH THAT THERE WAS A BACKOUT OF A SCREW AT THE LOWER END OF THE CONSTRUCT. ON (B)(6) 2015 THE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS THE BACKOUT. A FOLLOW UP APPOINTMENT ON (B)(6) 2015 REVEALED THE PATIENT IS DOING FINE POST REVISION AND THAT SPINAL FUSION HAS OCCURRED. NO PATIENT INJURY WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 6350159 ↗
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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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