ReLine 16015545Recalls & reported problems
Nuvasive, Inc. · RELINE MAS Screw, 5.5x45mm 2C 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 00887517553225), received between May 7, 2018 and May 7, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionMay 7, 2018Break; Break
ON (B)(6) 2017 PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE ON L3-5 LEVELS. DURING A POST-OPERATIVE DOCTOR VISIT PATIENT EXPRESSED HAVING NEW NEUROLOGICAL SYMPTOMS. AN MRI WAS ORDERED AND SHOWED A FRACTURED SCREW SHAFT AT THE RIGHT SIDE OF THE L5 LEVEL. PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FRACTURED SCREW HEAD AND L3 LEVEL SCREWS WERE REMOVED, CONSTRUCT WAS ALSO EXTENDED.
Patient problems: Failure of Implant
MAUDE report 7491202 ↗
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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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