ReLine 10000627Recalls & reported problems
Nuvasive, Inc. · RELINE-O Tap, 5.5mm Solid · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517512499), received between Jul 27, 2022 and Nov 20, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025Fracture; Fracture
THE TAP SNAPPED WHEN USING. THE PART WAS RETRIEVED NO ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23606896 ↗MalfunctionNov 15, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT POSTERIOR SPINAL FUSION PROCEDURE FROM L4-S1, DURING WHICH, THE TIP OF A TAP FRACTURED. ALL TAP PIECES WERE RETRIEVED. NO FURTHER CASE OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20696149 ↗MalfunctionFeb 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL FIXATION PROCEDURE. DURING THE PROCEDURE, THE PROXIMAL METAL RING OF THE TAP BROKE OFF OF THE INSTRUMENT AND WAS NOT RETRIEVED. AS A RESULT, THE RING WAS RETAINED IN THE PATIENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16288143 ↗MalfunctionJul 27, 2022Fracture; Fracture
ON (B)(6) 2022 DURING A CASE, THE TIP OF A RELINE TAP SHEERED OFF. ALL PIECES OF THE FRACTURED TAP WERE RETRIEVED. THERE WAS NO PATIENT IMPACT AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15113888 ↗
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- NIM TriVantage® 8229706Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls78 reports
- NIM-Response® 8253002Medtronic Xomed, Inc. · STIMULATOR, NERVE171 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 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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