ReLine 13115535Recalls & reported problems
Nuvasive, Inc. · RELINE-O Screw, 5.5x35mm Traction Poly · 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 00887517582201), received between Mar 11, 2021 and Mar 11, 2021 — classified as 1 injury.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Pneumothorax1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2021 A MALE PATIENT UNDERWENT A SPINAL PROCEDURE. DURING THE PROCEDURE IT WAS REPORTED THAT A PEDICLE SCREW PENETRATED THE ANTERIOR WALL OF THE VERTEBRAL BODY AT RIGHT TH3 AND CONTACTED THE PATIENTS LUNGS, RESULTING IN PNEUMOTHORAX. THE SCREW WAS REMOVED AND THE PHYSICIAN INSTALLED A CHEST TUBE AND RESUMED THE OPERATION. THE SURGEON BELIEVED HE MADE A MIS-SELECTION OF THE SCREW LENGTH AND HAD AN ERROR IN CREATING THE PILOT HOLE. THE PATIENT HAS RECOVERED FROM PNEUMOTHORAX AND IS DOING WELL.
Patient problems: Pneumothorax
MAUDE report 11464420 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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