ReLine 13115540Recalls & reported problems
Nuvasive, Inc. · RELINE-O Screw, 5.5x40mm Traction Poly · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517582218), received between Aug 14, 2017 and Jul 2, 2024 — classified as 1 injury, 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
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Noise, Audible1
- Unintended Movement1
Patient problems
- Failure of Implant1
- Pain1
- Paralysis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2024Fracture; Noise, Audible; Fracture; Noise, Audible
ON (B)(6) 2023 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L4-L5. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. ON A UNKNOWN DATE IN OCTOBER 2023 THE PATIENT WAS EXPERIENCING AN INTERNAL CRACKING SOUND SO SHE WENT IN TO THE DOCTOR WHERE IT WAS OBSERVED A SCREW HAD FRACTURED ON THE RIGHT SIDE OF THE CONSTRUCT AT THE L4 LEVEL. THE PATIENT WAS ASYMPTOMATIC SO NOTHING WAS DONE AT THAT TIME AND THE PATIENT CONTINUED TO BE OBSERVED. ON A UNKNOWN LATER DATE THE PATIENT BEGAN TO COMPLAIN OF PAIN. AS A RESULT ON (B)(6) 2024 A REVISION PROCEDURE OCCURRED WHERE THE ENTIRE CONSTRUCT WAS REMOVED AND NEW PEDICLE SCREWS WERE IMPLANTED. THE REVISION WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: Pain
MAUDE report 19657829 ↗InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2019, PATIENT UNDERWENT A PEDICLE SUBTRACTION OSTEOTOMY AT L3 WITH POSTERIOR FIXATION AT L2 TO L4 LEVELS. POST OPERATIVELY THE PATIENT EXPERIENCED PARALYSIS. AS PER REPORTER A REVISION PROCEDURE WAS PERFORMED TO REMOVE VERTEBRAL DISC AT L2 TO L3 AND A BONE FRAGMENT WHICH TOUCHED THE NERVE WAS REMOVED.
Patient problems: Paralysis
MAUDE report 8803465 ↗MalfunctionAug 14, 2017Unintended Movement; Unintended Movement
ON (B)(6) 2017, A PATIENT UNDERWENT POSTERIOR SPINAL FUSION AT THE T7-L2 LEVELS. ON (B)(6) 2017, A XRAY FILM INDICATED 4 SCREWS LOOSENING AT THE L1-L2 LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017, TO REPLACE THE LOOSENED SCREWS WITH SCREWS WITH THE LARGER DIAMETER. NO PATIENT INJURY WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 6792226 ↗
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 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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