ReLine 16017550Recalls & reported problems
Nuvasive, Inc. · RELINE MAS Screw, 7.5x50mm 2C Polyaxial · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517553959), received between Apr 14, 2020 and Jun 8, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (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
- Difficult or Delayed Separation1
- Migration1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2022Difficult or Delayed Separation; Difficult or Delayed Separation
ON (B)(6) 2022 A PATIENT UNDERWENT AN POSTERIOR FIXATION PROCEDURE. DURING THE PROCEDURE A SCREW WAS ENGAGED TO A GUIDE AND INSERTED INTO THE VERTEBRAL BODY. THE GUIDE COULD NOT DISENGAGE THE SCREW SO BOTH THE SCREW AND GUIDE WERE REMOVED FROM THE PATIENT. A NEW GUIDE AND SCREW WERE USED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14633692 ↗MalfunctionApr 14, 2020Migration; Migration
ON (B)(6) 2019 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L2-3 AND L4-5 USING COROENT XL. ON (B)(6) 2019 THE SECONDARY PROCEDURE, A POSTERIOR FIXATION, WAS PERFORMED. ON (B)(6) 2020 A REVISION PROCEDURE WAS PERFORMED DUE TO A PEDICLE SCREW LOOSENING AT L2 DUE TO LOCAL KYPHOSIS. THE PEDICLE SCREW WAS REPLACED BY A NEW ONE.
Patient problems: Failure of Implant
MAUDE report 9960716 ↗
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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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