ReLine D10000955Recalls & reported problems
Nuvasive, Inc. · RELINE MAS MOD Shankdriver, 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 00887517652065), received between Apr 3, 2023 and Sep 11, 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
- Structural Problem1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2025Fracture; Fracture
THE DRIVER TIP BROKE OFF INSIDE SCREW SHANK. IT WAS UNABLE TO BE RETRIEVED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23030446 ↗MalfunctionMar 22, 2024Structural Problem; Structural Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE DRIVER'S CANNULATION WAS FOUND TO BE CLOGGED WITH AN UNIDENTIFIED MATERIAL. ANOTHER DRIVER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18963390 ↗MalfunctionApr 3, 2023Fracture; Fracture
ON (B)(6), 2022 DURING A SPINAL PROCEDURE AT L4/5 THE TIP OF THE SHANKDRIVER BROKE INSIDE SCREW. ON MARCH 14, ADDITIONAL INFO WAS PROVIDED THAT THE TIP WAS LEFT IN-SITU IN THE RIGHT SCREW AT L4 AND WAS COVERED BY THE ROD. NO PATIENT INJURY OR SURGICAL DELAYS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 16668527 ↗
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- NIM TriVantage® 8229706Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls78 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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