ReLine 13014545Recalls & reported problems
Nuvasive, Inc. · RELINE-O Screw, 4.5x45mm 2S Polyaxial · Class 2 · Implant
- 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 00887517536495), received between Aug 8, 2017 and Aug 8, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Unintended Movement1
Patient problems
- 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.
MalfunctionAug 8, 2017Unintended Movement; Unintended Movement
POST-OPERATIVE FOLLOW UP IDENTIFIED 4 SCREWS BACKED OUT AT T10-12 LEVELS AND AS A RESULT THE TIP OF THE LEFT SIDE ROD PROTRUDED THROUGH THE INCISION SITE. ON (B)(6) 2017, A REVISION SURGERY WAS PERFORMED REPLACING THE 4 SCREWS AT T10-T12 LEVELS. THE PROTRUDED ROD TIP WAS BENT VENTRALLY AND THE SURGICAL SITE WAS WASHED TO DETER INFECTION. NO ADDITIONAL ISSUES OR INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 6775087 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.