ReLine 13017550Recalls & reported problems
Nuvasive, Inc. · RELINE-O Screw, 7.5x50mm 2S Polyaxial · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517537584), received between Dec 21, 2017 and Dec 21, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
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.
MalfunctionDec 21, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2017, A PATIENT HAD A POSTERIOR FIXATION PROCEDURE AT L3 TO S1 LEVELS WITHOUT ANY REPORTED ISSUES. ON (B)(6) 2017 DURING FOLLOW UP, RADIOGRAPHS SHOWED THE TWO TOP PEDICLE SCREWS HAD BACKED OUT. ON (B)(6) 2017 A REVISION PROCEDURE WAS PERFORMED REPLACING THE TWO SCREWS AND EXTENDING THE CONSTRUCT TO L2 LEVEL WITH NO RECORDED ISSUES OR PATIENT INJURY.
Patient problems: Failure of Implant
MAUDE report 7139116 ↗
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- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
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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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