ReLine 13117545Recalls & reported problems
Nuvasive, Inc. · RELINE-O Screw, 7.5x45mm Traction Poly · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 18, 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 00887517582782), received between Aug 9, 2019 and Sep 23, 2021 — classified as 2 malfunctions.
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 18, 2026.
Most reported problems
Device problems
- Malposition of Device1
- Unintended Movement1
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.
MalfunctionSep 23, 2021Malposition of Device; Malposition of Device
ON (B)(6) 2021 A PATIENT UNDERWENT A EXTREME LATERAL INTERBODY FUSION PROCEDURE FROM L3 TO L5 FIXED WITH POSTERIOR FIXATION. ON A UNKNOWN DATE IT WAS DISCOVERED THAT THE RIGHT SCREW AT L5 WAS DEVIATED INWARD. THIS DEVIATION WAS CONFIRMED TO BE THE RESULT OF PROPER TRAJECTORY NOT BEING ACHIEVED IN THE INDEX PROCEDURE. ON (B)(6) 2021 A REVISION OCCURRED WHERE THE DEVIATED SCREW WAS RE USED AND PUT IN THE PROPER POSITION. THE WAS NO REPORT OF ANY ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE MALPLACED SCREW AND THE PATIENT IS CONSIDERED TO BE RECOVERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12523456 ↗MalfunctionAug 9, 2019Unintended Movement; Unintended Movement
ON (B)(6) 2019 PATIENT UNDERWENT A FUSION PROCEDURE ON L4 TO S1 VERTEBRAL LEVELS. AS PER REPORTER THE PROCEDURE WAS SUCCESSFUL WITH NO REPORTED ISSUES. PATIENT REPORTED TO HAVE EXPERIENCED BAD COUGHING AND SNEEZING AND FELT A POP. DURING A 6 WEEK FOLLOW UP APPOINTMENT IT WAS DISCOVERED VIA XRAY THAT THE RODS WERE DAMAGED AND A SCREWS BACK OUT. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2019 WHERE ALL SCREWS AND RODS WERE REMOVED.
Patient problems: Failure of Implant
MAUDE report 8878471 ↗
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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