ReLine 13116550Recalls & reported problems
Nuvasive, Inc. · RELINE-O Screw, 6.5x50mm Traction Poly · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 18, 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 00887517582515), received between Jul 9, 2019 and Jul 9, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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 18, 2026.
Most reported problems
Device problems
- Migration1
Patient problems
- Bone Fracture(s)1
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2019Migration; Migration
ON (B)(6) 2019, PATIENT UNDERWENT A VERTEBRAL REPLACEMENT PROCEDURE AT L3 WITH POSTERIOR SPINAL FUSION AT L1, L2 AND L4 LEVELS. AS PER REPORTER, ON (B)(6), IT WAS CONFIRMED SCREWS AT L4 WERE SINKING, CRACKED BONE AND X-CORE MIGRATION. ON (B)(6), A REVISION PROCEDURE WAS PERFORMED. ALL SCREWS AT L1, L2 AND L4 WERE REPLACED WITH NEW ONES AND THE POSTERIOR FUSION WAS EXTENDED TO L5. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 8771814 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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