ReLine 11355040Recalls & reported problems
Nuvasive, Inc. · RELINE MAS Ti Rod, 5.5x40mm Lordotic · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517505002), received between May 31, 2018 and Jul 29, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Migration1
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2020Migration; Migration
ON (B)(6) 2020 A MAXIMUM ACCESS SURGERY TRANSFORAMINAL LATERAL INTERBODY FUSION WAS PERFORMED ON L4/S1. RADIOGRAPHS REVEAL LEFT SIDE ROD-SEPARATION FROM S1 TO L5 AND CAGE-MIGRATION AT S1/L5.
Patient problems: Failure of Implant
MAUDE report 10342307 ↗MalfunctionMay 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
REPORTEDLY ON FEBRUARY 21, 2018 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE WITH A LATERAL PLATE AND POSTERIOR FIXATION AT L4-L5 LEVELS WITHOUT ANY REPORTED ISSUES. FOLLOW UP RADIOGRAPHS SHOWED A ROD SEPARATION AT L1 LEVEL. ON (B)(6) 2018 A REVISION PROCEDURE TOOK PLACE WHERE THE POSTERIOR FIXATION WAS REMOVED AND REPLACED WITHOUT REPORTED ISSUE. NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 7558629 ↗
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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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