Archon 8780417Recalls & reported problems
Nuvasive, Inc. · Archon Screw, 4.0x17mm 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517200334), received between Mar 23, 2017 and Mar 23, 2017 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Fall1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2015 A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT A 4-LEVEL ACDF PROCEDURE FROM C3 TO C7. SIX MONTHS AFTER INDEX SURGERY THE PATIENT FELL, AFTER WHICH THE PATIENT REPORTED INCREASED CERVICAL PAIN. A MRI SHOWED SPINAL CANAL NARROWING AT C4 AND C5 WITH EVIDENCE OF EDEMA. CT IMAGES DEMONSTRATED SUBSIDENCE OF C3 INTERBODY GRAFT. AS A RESULT OF THE IMPACT, INSTABILITY INCREASED; A POSTERIOR CERVICAL FUSION CONSTRUCT WAS ADDED ON (B)(6) 2016. THE REVISION SURGERY WAS COMPLICATED BY A POST-OPERATIVE INFECTION REQUIRING WOUND DEBRIDEMENT AND IV ANTIBIOTICS. PATIENT HAS RECOVERED FROM THE REPORTED INFECTION.
Patient problems: Fall; Pain; Unspecified Infection
MAUDE report 6430518 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page