PROTEX 109.521Recalls & reported problems
Globus Medical, Inc. · 6.00mm Straight Rod, 500mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889095034783), received between Sep 8, 2020 and Mar 12, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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
- Break3
- Fracture1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
- Spinal Column Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2024Fracture; Fracture
IT WAS REPORTED THAT A REVISION WAS COMPLETED FOR A PROTEX ROD THAT WAS FOUND BROKEN IN THE PATIENT POST OPERATIVELY.
Patient problems: Spinal Column Injury
MAUDE report 18888338 ↗MalfunctionMar 1, 2024Break; Break
IT WAS REPORTED THAT POST-OPERATIVE IMAGING SHOWED A ROD BREAKAGE IN THE LOWER THORACIC SPINE. REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN ROD.
Patient problems: Insufficient Information
MAUDE report 18817066 ↗MalfunctionSep 23, 2020Break
IT WAS REPORTED THAT POST-OPERATIVELY A ROD BREAKAGE WAS FOUND BILATERALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10575532 ↗MalfunctionSep 8, 2020Break
IT WAS REPORTED THAT A BILATERAL ROD BREAKAGE OCCURRED POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 10504491 ↗
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 16, 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