Helix 7734117Recalls & reported problems
Nuvasive, Inc. · Helix ACP Screw, 4x17mm Fixed Self Tap · Class 2 · Implant
All models of Helix (15)
Data updated Oct 16, 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 00887517091758), received between Apr 28, 2017 and Jul 27, 2017 — classified as 2 malfunctions.
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
- Migration or Expulsion of Device1
- Unintended Movement1
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.
MalfunctionJul 27, 2017Migration or Expulsion of Device; Unintended Movement; Migration or Expulsion of Device; Unintended Movement
ON (B)(6) 2017 PATIENT UNDERWENT A REVISION SURGERY DUE TO HELIX SCREW BACKOUT. PATIENT WAS REPORTED TO HAVE NO ISSUES POST SURGERY.
Patient problems: Failure of Implant
MAUDE report 6748522 ↗MalfunctionApr 28, 2017Fracture; Fracture
A (B)(6) YEAR-OLD PATIENT UNDERWENT A SINGLE-LEVEL ACDF PROCEDURE AT C5-6 ON (B)(6) 2014. APPROXIMATELY (B)(6) 2016 THE PATIENT REPORTED A RETURN OF RADICULAR SYMPTOMS WITH NUMBNESS. EVALUATION CONDUCTED FEBRUARY 22, 2017 NOTED A SCREW FRACTURE IN THE C6 VERTEBRAL BODY. REVISION OF THE INDEX SURGERY CONSTRUCT IS ANTICIPATED. NO INJURY HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 6530333 ↗
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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