ReLine 13114540Recalls & reported problems
Nuvasive, Inc. · RELINE-O Screw, 4.5x40mm 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517581938), received between Aug 8, 2017 and Sep 20, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (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
- Adverse Event Without Identified Device or Use Problem1
- Unintended Movement1
Patient problems
- Bone Fracture(s)1
- Failure of Implant1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2019, A PATIENT UNDERWENT VERTEBRAL REPLACEMENT AT L2 USING X-CORE AND POSTERIOR SPINAL FUSION AT L1-L3 USING RELINE. AS PER REPORTER, A FRACTURE AT L1 LEVEL WAS IDENTIFIED THREE WEEKS POST OPERATIVELY. ON (B)(6) 2019 A REVISION PROCEDURE WAS PERFORMED, AND THE FIXATION WAS EXTENDED TO T11-L4.
Patient problems: Bone Fracture(s)
MAUDE report 9099732 ↗MalfunctionAug 8, 2017Unintended Movement; Unintended Movement
ON (B)(6) 2017, A PATIENT UNDERWENT A LATERAL INTERBODY FUSION PROCEDURE THEN ADDED POSTERIOR FIXATION AT L1-S1 LEVEL ON (B)(6) 2017. POST-OPERATIVE FOLLOW UP IDENTIFIED 4 SCREWS BACKED OUT AT L1-2 LEVELS. ON (B)(6) 2017 A REVISION SURGERY WAS PERFORMED REPLACING THE 4 SCREWS AS WELL AS EXTENDING THE CONSTRUCT FROM T12 TO T10 LEVELS.
Patient problems: Failure of Implant
MAUDE report 6775080 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
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- 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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