ReLine 16087545Recalls & reported problems
Nuvasive, Inc. · RELINE MAS Trauma Screw, 7.5x45mm Cann · 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 00887517560056), received between Aug 14, 2019 and Oct 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2024Fracture; Fracture
ON AN UNKNOWN DATE A PATIENT UNDERWENT A POSTERIOR SPINAL FIXATION PROCEDURE FROM L1 TO L5. ON AN UNKNOWN DATE, IT WAS FOUND THAT ONE OF THE PEDICLE SCREWS AT THE L2 LOCATION AND THE ASSOCIATED FIXATION ROD HAD FRACTURED. A REVISION PROCEDURE WAS CONDUCTED ON (B)(6) 2024 FOR WHICH THE FRACTURED SCREW HEAD AND ROD WERE REMOVED AND REFIXATION WAS CONDUCTED. NO ADDITIONAL INFORMATION WAS OBTAINED. (REPORT 1 OF 2).
Patient problems: Insufficient Information
MAUDE report 20434440 ↗MalfunctionAug 14, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
IN (B)(6) 2018, A PATIENT UNDERWENT A PROCEDURE FROM VERTEBRAL LEVEL L2 TO L4. SCREWS WERE PLACED PERCUTANEOUSLY TO BRACE A FRACTURE. DURING A FOLLOW UP APPOINTMENT IN (B)(6) 2019, RADIOGRAPHS IDENTIFIED THAT THE SCREWS HAD LOOSENED PREMATURELY AND WOULD NEED TO BE REMOVED. ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 8893933 ↗
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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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