Helix 7803113Recalls & reported problems
Nuvasive, Inc. · Helix R Screw, 4x13mm Var Self-Tap · Class 2 · Implant
Data updated Oct 13, 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 00887517138910), received between Feb 22, 2017 and Feb 24, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Migration or Expulsion of Device2
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.
MalfunctionFeb 24, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2013 A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT A 4 LEVEL PROCEDURE FROM C3 TO C7 SPINE LEVELS. DURING A 24-MONTH FOLLOW UP APPOINTMENT IT WAS DISCOVERED THE SCREWS AT THE C7 LEVEL HAD BEGAN TO BACK OUT SLIGHTLY COMPARED TO THE 1 YEAR FOLLOW UP. THE LOOSENED SCREWS REMAIN IN THE PATIENT. NO PLAN FOR REVISION IS KNOWN. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 6358274 ↗MalfunctionFeb 22, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2013 A (B)(6) MALE PATIENT UNDERWENT A 3-LEVEL PROCEDURE FROM C4 TO C7. DURING THE 6-MONTH FOLLOW-UP APPOINTMENT RADIOGRAPHIC REVIEW NOTED THAT A SCREW AT THE C7 LEVEL HAD LOOSENED. A REVISION SURGERY TOOK PLACE ON (B)(6) 2014 TO CORRECT THE REPORTED EVENT. THE PATIENT IS DOING WELL POST REVISION. NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 6350152 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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