ReLine 3904530Recalls & reported problems
Nuvasive, Inc. · RELINE C Screw, 4.5x30mm MA · 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 00195377069061), received between May 15, 2023 and May 15, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
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.
MalfunctionMay 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AFTER THE INITIAL SURGERY ON UNKNOWN DATE, PATIENT REPORTED ACCIDENT OCCURRING IN HER GARAGE WHILE USING HAMMER. DR. TEMPEL NOTICED LOOSENED SET SCREWS ON AN X-RAY FOLLOWING THIS ACCIDENT. AT THAT TIME, TEMPEL SCHEDULED FOR A REVISION THAT OCCURRED ON (B)(6) 2023. DURING THE REVISION, TEMPEL TESTED THE INTEGRITY OF THE SCREWS WITH A LEKSELL. WITH LIGHT PRESSURE, THE TULIP HEAD CAME OFF THE SHANK SCREW. TEMPEL REMOVED BOTH SHANKS AND REPLACED WITH A LARGER DIAMETER SCREW. (2 OF 2).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931305 ↗MalfunctionMay 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AFTER THE INITIAL SURGERY ON UNKNOWN DATE, PATIENT REPORTED ACCIDENT OCCURRING IN HER GARAGE WHILE USING HAMMER. DR. TEMPEL NOTICED LOOSENED SET SCREWS ON AN X-RAY FOLLOWING THIS ACCIDENT. AT THAT TIME, TEMPEL SCHEDULED FOR A REVISION THAT OCCURRED ON (B)(6) 2023. DURING THE REVISION, TEMPEL TESTED THE INTEGRITY OF THE SCREWS WITH A LEKSELL. WITH LIGHT PRESSURE, THE TULIP HEAD CAME OFF THE SHANK SCREW. TEMPEL REMOVED BOTH SHANKS AND REPLACED WITH A LARGER DIAMETER SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931006 ↗
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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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