Archon 8780213Recalls & reported problems
Nuvasive, Inc. · Archon Screw, 4.0x13mm Self-Drill Var · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517199850), received between May 5, 2021 and May 5, 2021 — classified as 1 death.
The most frequently reported specific device problem is “Malposition 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
- Malposition of Device1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMay 5, 2021Malposition of Device; Malposition of Device
A PATIENT UNDERWENT A CERVICAL PROCEDURE ON C3/C5. POST SCREW INSERTION, THE SURGEON OBSERVED SIGNIFICANT BLEEDING FROM ONE OF THE SCREW HOLES. HE REMOVED ALL IMPLANTS TO GAIN CONTROL OF THE BLEEDING. IT WAS ESTIMATED A POSSIBLE 4 UNITS OF BLOOD WERE GIVEN IN THE CASE WITH MORE BEING PROVIDED POST OP. THE BLEEDING WAS THE RESULT OF A VERTEBRAL ARTERY INJURY. ONCE IN CONTROL OF THE BLEEDING THE IMPLANTS WERE REINSTALLED AND THE SURGERY WAS COMPLETED. ON (B)(6) 2021, WE WERE NOTIFIED THE PATIENT HAD PASSED AWAY.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)
MAUDE report 11776219 ↗
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- 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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