ReLine 10000831Recalls & reported problems
Nuvasive, Inc. · RELINE MAS Screwdriver, Cannulated Red · 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 00887517589064), received between Oct 14, 2021 and Oct 14, 2021 — 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.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 14, 2021Fracture; Fracture
ON (B)(6) 2021 A PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE FROM L2-L4. DURING THE PROCEDURE THE DISTAL TIP OF AN ENGAGED DRIVER FRACTURED OFF INTO A SCREW HEAD ON THE LEFT SIDE AT L3. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. POST-OPERATIVE MRI IMAGES SHOWED HALATION AND THE SALES REP DISCOVERED THE DRIVER TIP HAD FRACTURED OFF. ON (B)(6) 2021 A REVISION OCCURRED TO REMOVE THE FRACTURED DRIVER TIP THAT RESULTED IN THE WHOLE SCREW NEEDING TO BE REPLACED DUE TO AN INABILITY TO FREE THE FRACTURED PORTION. THE REVISION WAS COMPLETED WITHOUT ISSUE AND THE PATIENT IS REPORTED TO BE RECOVERING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12636201 ↗
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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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