Archon 8780615Recalls & reported problems
Nuvasive, Inc. · Archon Screw, 4.5x15mm Self-Tap Var · 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 00887517202871), received between May 9, 2019 and May 9, 2019 — 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.
MalfunctionMay 9, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2019 A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY FUSION PROCEDURE AT LEVELS C3-7. AS PER REPORTER SURGEON EXPERIENCED DIFFICULTY WITH 4 OUT OF 5 CAMS LOCKS PARTIALLY LOCKING AND THE BOTTOM CAM LOCK DETACHED FROM THE PLATE. ON (B)(6) 2019 DURING FOLLOW UP RADIOGRAPHS IDENTIFIED BOTH OF THE INFERIOR SCREWS HAD BACKED OUT WITH NO REPORTED PATIENT SYMPTOMS. ON (B)(6) 2019 A REVISION PROCEDURE TOOK PLACE WHERE THE PLATE WAS REMOVED AND REPLACED WITH ANOTHER VENDOR¿S DEVICE WITH NO REPORTED ISSUES OR PATIENT INJURY.
Patient problems: Failure of Implant
MAUDE report 8597914 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
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- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
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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