ReLine 13114545Recalls & reported problems
Nuvasive, Inc. · RELINE-O Screw, 4.5x45mm Traction Poly · Class 2 · Implant
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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517581945), received between Jun 1, 2021 and Jun 1, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hematoma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2021 A SPINAL PROCEDURE WAS CONDUCTED AT T9/S2, L3 WAS SKIPPED AND IT WAS REPORTED COMPETITOR'S HARDWARE WAS USED. AN OSTEOTOMY WAS PERFORMED AT L3. POST-OP A HEMATOMA WAS DISCOVERED NEAR LEFT L3/4 THAT WAS CAUSING PARALYSIS. ON (B)(6) 2021 A REVISION SURGERY WAS CONDUCTED TO REMOVE THE HEMATOMA. DURING THE REVISION SURGERY THE LEFT ROD WAS REMOVED THEN RE-INSTALLED AND THE LOCK SCREWS WERE REPLACED.
Patient problems: Hematoma
MAUDE report 11914716 ↗
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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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