Helix 7802215Recalls & reported problems
Nuvasive, Inc. · Helix R Screw, 4x15mm Fixed Self-Drill · Class 2 · Implant
All models of Helix (15)
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 00887517138477), received between Dec 20, 2015 and Dec 20, 2015 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
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.
MalfunctionDec 20, 2015Fracture
ON (B)(6) 2015 A (B)(6) MALE WAS IMPLANTED WITH A HELIX REVOLUTION ACP SYSTEM AT C4-C6 WITH A MEDTRONIC CORNERSTONE ALLOGRAFT. ON (B)(6) 2015 AT THE THREE MONTH POSTOPERATIVE VISIT IT WAS NOTED THAT THE SCREW WAS STARTING TO BEND. ON (B)(6) 2015 RADIOGRAPH CONFIRMED THE SCREW HAD FRACTURED. DURING ONE OF THE OFFICE VISITS, PATIENT COMPLAINED OF ARM PAIN. THE SURGEON HAS ELECTED TO MONITOR THE PATIENT'S CONDITION. DEVICE REMAINS IN-SITU. NO REVISION SURGERY IS SCHEDULED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 5312936 ↗
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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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