ReLine 13117550Recalls & reported problems
Nuvasive, Inc. · RELINE-O Screw, 7.5x50mm Traction Poly · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517582799), received between Feb 20, 2023 and Feb 20, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 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
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL FOUR (4) LEVEL OPEN POSTERIOR FIXATION PROCEDURE FROM T11 TO L3. SUBSEQUENTLY, ON AN UNKNOWN DATE, BILATERAL FRACTURE OF THE PEDICLE SCREWS AT THE L3 VERTEBRAE WAS IDENTIFIED. BONE FUSION WAS NOTED TO BE COMPLETE. THE PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE SCREWS APPROXIMATELY THREE (3) YEARS AFTER THE INITIAL SURGERY. THE DEVICES WERE SUCCESSFULLY EXPLANTED WITH ONLY THE DISTAL PORTIONS OF THE BILATERAL FRACTURED SCREWS RETAINED IN THE L3 VERTEBRAE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. REPORT 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16403456 ↗InjuryFeb 20, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL FOUR (4) LEVEL OPEN POSTERIOR FIXATION PROCEDURE FROM T11 TO L3. SUBSEQUENTLY, ON AN UNKNOWN DATE, BILATERAL FRACTURE OF THE PEDICLE SCREWS AT THE L3 VERTEBRAE WAS IDENTIFIED. BONE FUSION WAS NOTED TO BE COMPLETE. THE PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE SCREWS APPROXIMATELY THREE (3) YEARS AFTER THE INITIAL SURGERY. THE DEVICES WERE SUCCESSFULLY EXPLANTED WITH ONLY THE DISTAL PORTIONS OF THE BILATERAL FRACTURED SCREWS RETAINED IN THE L3 VERTEBRAE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE. REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16401807 ↗
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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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