ReLine 13015035Recalls & reported problems
Nuvasive, Inc. · RELINE-O Screw, 5.0x35mm 2S Polyaxial · 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 00887517536655), received between Jul 6, 2022 and Jul 6, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 6, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE TO EXTEND AN EXISTING T8 TO S1 FIXATION CONSTRUCT TO INCLUDE T3 TO T7 FOR THE TREATMENT OF ADJACENT SEGMENT KYPHOSIS. SUBSEQUENTLY, REVIEW OF CT SCANS OBTAINED THE FOLLOWING DAY IDENTIFIED THAT THE RIGHT PEDICLE SCREW AT THE T7 VERTEBRAE WAS BREACHING THE SPINAL CANAL. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPOSITION THE PEDICLE SCREW. THE PATIENT REPORTED NO SYMPTOMS ASSOCIATED WITH THE MALPOSITIONED SCREW. NO FURTHER IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14940775 ↗
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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