ReLine 10001118Recalls & reported problems
Nuvasive, Inc. · RELINE-O Guide, Quick Connect Fen · Class 1
All models of ReLine (129)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517948397), received between Sep 26, 2023 and Sep 26, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination” (3 reports).
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
- Contamination3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2023Contamination; Contamination
ON (B)(6) 2023 A PATIENT UNDERWENT ANESTHESIA FOR A SCHEDULED POSTERIOR FIXATION PROCEDURE. ABOUT 15 MINUTES INTO THE CASE IT WAS DISCOVERED THREE OF THE CEMENT GUIDES WERE JAMMED WITH REMNANTS OF CEMENT FROM A PREVIOUS CASE. THE SURGEON WAS ALERTED TO THE CONTAMINANT AND MADE THE DECISION TO ABANDON THE PROCEDURE AS CEMENT AUGMENTATION WAS DEEMED CRITICAL TO A SUCCESSFUL OUTCOME FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17821703 ↗MalfunctionSep 26, 2023Contamination; Contamination
ON (B)(6) 2023 A PATIENT UNDERWENT ANESTHESIA FOR A SCHEDULED POSTERIOR FIXATION PROCEDURE. ABOUT 15 MINUTES INTO THE CASE IT WAS DISCOVERED THREE OF THE CEMENT GUIDES WERE JAMMED WITH REMNANTS OF CEMENT FROM A PREVIOUS CASE. THE SURGEON WAS ALERTED TO THE CONTAMINANT AND MADE THE DECISION TO ABANDON THE PROCEDURE AS CEMENT AUGMENTATION WAS DEEMED CRITICAL TO A SUCCESSFUL OUTCOME FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17821621 ↗MalfunctionSep 26, 2023Contamination; Contamination
ON (B)(6) 2023 A PATIENT UNDERWENT ANESTHESIA FOR A SCHEDULED POSTERIOR FIXATION PROCEDURE. ABOUT 15 MINUTES INTO THE CASE IT WAS DISCOVERED THREE OF THE CEMENT GUIDES WERE JAMMED WITH REMNANTS OF CEMENT FROM A PREVIOUS CASE. THE SURGEON WAS ALERTED TO THE CONTAMINANT AND MADE THE DECISION TO ABANDON THE PROCEDURE AS CEMENT AUGMENTATION WAS DEEMED CRITICAL TO A SUCCESSFUL OUTCOME FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17821161 ↗
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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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