ReLine 16086545Recalls & reported problems
Nuvasive, Inc. · RELINE MAS Trauma Screw, 6.5x45mm Cann · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517559692), received between Feb 18, 2026 and Feb 18, 2026 — classified as 1 injury.
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
Patient problems
- Spinal Column Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2026Fracture
IT WAS REPORTED THAT THE PATIENT SUFFERED A FRACTURE OF THE FIRST LUMBAR VERTEBRA. POSTERIOR FIXATION WAS PERFORMED FROM TH12 TO L2 ON (B)(6) 2024. THE SURGEON CONFIRMED SPINAL SCREW THAT HAD BEEN INSERTED INTO THE RIGHT SIDE OF THE SECOND LUMBAR VERTEBRA, HAD BROKEN BY CT IMAGING. A SECOND SURGERY WAS PERFORMED TO REMOVE IT. THE THREAD PART REMAINED IN THE BONE SINCE IT WAS DIFFICULT TO REMOVE IT FROM THE BONE. WE DO NOT RECEIVE ANY OTHER ADVERSE PATIENT CONSEQUENCES REPORTED. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 24381094 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
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- CD HORIZON® Spinal System 7578302Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis122 reports
- EXPEDIUM 179762480Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis114 reports
- ReLine 13550000Nuvasive, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis55 reports
- CD HORIZON® Spinal System 5440030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis50 reports
- EXPEDIUM 179712640Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis28 reports
- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM 179788635Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
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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