ReLine 11000443Recalls & reported problems
Nuvasive, Inc. · NAV.S RELINE Tap, 4.5mm Cannulated · Class 2
All models of ReLine (129)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517955494), received between Oct 30, 2023 and Aug 25, 2025 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2025Fracture; Fracture
THE 4.5MM TAP BROKE OFF IN THE PEDICLE OF THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22883610 ↗MalfunctionJan 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CANNULA OF 4.5 TAP IS BLOCKED AND NO LONGER CANNULATED. NO SURG PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18451725 ↗MalfunctionOct 30, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE DISTAL TIP OF THE TAP FRACTURED OFF. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT AND THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18033212 ↗
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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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