Archon 8780215Recalls & reported problems
Nuvasive, Inc. · Archon Screw, 4.0x15mm Self-Drill Var · Class 2 · Implant
Data updated Oct 13, 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 00887517202338), received between Feb 24, 2017 and Feb 12, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Migration or Expulsion of Device2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2018Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2017 PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION AT LEVELS C4/5, C5/6 AND C6/7. ONE MONTH POST-OPERATIVE PATIENT WAS INFORMED TWO LOCKING SCREWS HAD BACK OUT AT LEVELS C4/5 AND C6/7. NO REVISION PROCEDURE HAS BEEN PLANNED. PATIENT WILL CONTINUE TO BE MONITORED.
Patient problems: Failure of Implant
MAUDE report 7263742 ↗MalfunctionFeb 24, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2015 A (B)(6) YEARS OLD FEMALE PATIENT UNDERWENT A 3 LEVEL PROCEDURE ON C3 TO C4 AND C5 TO C7. DURING A 3 MONTH FOLLOW UP APPOINTMENT, IT WAS DISCOVERED THERE WAS A POSSIBLE LOOSENING OF THE SCREWS AT C7. AT THE 12 MONTH FOLLOW UP IT WAS CONFIRMED THAT THE SCREWS LOOSENED AT C7 AND SHOWED INFERIOR MIGRATION. THE BACKED OUT SCREWS REMAIN IN THE PATIENT. NO REVISION IS PLANNED. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 6358510 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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