ReLine 11000445Recalls & reported problems
Nuvasive, Inc. · NAV.S RELINE Tap, 5.5mm Cannulated · Class 2
All models of ReLine (129)
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 00887517955517), received between Dec 30, 2024 and Dec 30, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE WHEN PERFORMING HOLE PREPARATION ON THE RIGHT SIDE OF THE SACRUM THE TIP OF A TAP BECAME STUCK. WHEN ATTEMPTING TO REMOVE THE DEVICE FROM THE BONE, THE TIP FRACTURED OFF. THE FRACTURED PORTION WAS RETAINED IN THE BONE AND THE SURGEON OPTED TO LEAVE THE PORTION IN SITU. NO FURTHER PATIENT IMPACT WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 21044668 ↗
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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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