ReLine 13015540Recalls & reported problems
Nuvasive, Inc. · RELINE-O Screw, 5.5x40mm 2S Polyaxial · 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 00887517536846), received between Mar 4, 2016 and Feb 3, 2022 — classified as 2 malfunctions.
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
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2022Fracture; Fracture
ON (B)(6) 2022 A PATIENT UNDERWENT A REVISION PROCEDURE TO EXTEND A PRE EXISTING CONSTRUCT AT L3-L5 TO T9-PELVIS DUE TO A CONTINUED DECLINE IN PATIENT PATHOLOGY. DURING THE HARDWARE REMOVAL PORTION OF THE REVISION SURGERY IT WAS DISCOVERED THAT THE RIGHT SCREW AT L5 HAD FRACTURED. AS A CONSEQUENCE THE FRACTURED PORTION WAS LEFT IN PATIENT. THE REMAINDER OF THE REVISION OCCURRED WITHOUT ISSUE AND THE PATIENT IS CURRENTLY RECOVERING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13444144 ↗MalfunctionMar 4, 2016Fracture; Fracture
ON (B)(6) 2015, A (B)(6) FEMALE PATIENT RECEIVED AN IMPLANT POSTERIORLY AT L4 - S1 WITH NO INTERBODIES USED. APPROXIMATELY TWO MONTHS POSTOPERATIVELY, RADIOGRAPHS SHOWED THAT THE LEFT S1 SCREW SHANK FRACTURED HALFWAY DOWN THE SCREW SHANK ITSELF. DEVICE REMAINS IN-SITU. NO REVISION SURGERY IS SCHEDULED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 5480814 ↗
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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