ReLine 16027550Recalls & reported problems
Nuvasive, Inc. · RELINE MAS Red Screw, 7.5x50mm Poly 2C · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517557001), received between Sep 20, 2019 and Aug 4, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Decoupling” (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
- Decoupling1
- Fracture1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2020Decoupling; Migration or Expulsion of Device; Decoupling; Migration or Expulsion of Device
ON (B)(6) A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE. DURING A POST-OP FOLLOW UP, AN X-RAY DISCOVERED THAT A SCREW TULIP HAD DISSOCIATION AND THE ROD HAD SLIPPED AT S1 LEVEL. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020. PATIENT WAS REPORTED AS ASYMPTOMATIC.
Patient problems: Failure of Implant
MAUDE report 10365831 ↗InjurySep 20, 2019Fracture; Fracture
ON (B)(6) 2019 A PATIENT UNDERWENT A SPINAL PROCEDURE, POST OPERATIVE RADIOGRAPHS REVEALED A SCREW TAB REMAINED IN SITU. A REVISION PROCEDURE WAS CONDUCTED THE SAME DAY AND THE TAB WAS SUCCESSFULLY REMOVED. NO PATIENT INJURY REPORTED.
Patient problems: No Code Available
MAUDE report 9099894 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page