Helix 7803117Recalls & reported problems
Nuvasive, Inc. · Helix R Screw, 4x17mm Var 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 00887517138958), received between Mar 10, 2016 and Dec 17, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
Patient problems
- Failure of Implant1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2018Fracture; Fracture
ON (B)(6) 2018 PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY FUSION FROM C3-C6 LEVELS WITH NO REPORTED COMPLICATIONS. ON (B)(6) 2018 THE PATIENT FELT A POP AND RESIDUAL PAIN, RADIOGRAPHS SHOWED A FRACTURED SCREW AT THE LEFT SIDE OF C6 LEVEL. THE SURGEON NOTED FUSION HAD BEEN ACHIEVED AND NO REVISION WILL BE PERFORMED.
Patient problems: Pain
MAUDE report 8169578 ↗MalfunctionMar 10, 2016Fracture; Fracture
ON (B)(6) 215 A MALE PATIENT UNDERWENT AN ACDF PROCEDURE WITH NO COMPLICATIONS. AT THREE MONTH FOLLOW-UP, THE CONSTRUCT WAS NOTED TO BE INTACT. AT SIX MONTH FOLLOW-UP, RADIOGRAPHS SHOWED A SCREW HAD FRACTURED AT C7. SURGEON HAS ELECTED TO MONITOR THE PATIENT, NO REVISION SURGERY IS PLANNED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 5493830 ↗
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- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
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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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