TRANSITION 152.784SRecalls & reported problems
Globus Medical, Inc. · TRANSITION 8.5mm MIS HA Polyaxial Pedicle Screw, 40mm · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849044084412), received between Mar 4, 2024 and Mar 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT POST-OPERATIVE IMAGING FOUND THE HA SCREWS PLACED AT L4-5 WERE SOLID; HOWEVER, HALOING AROUND THE S1 HA SCREW INDICATED THE SCREW WAS MOBILE. A REVISION SURGERY WAS PERFORMED TO REMOVE THE LOOSENED SCREW.
Patient problems: Failure of Implant
MAUDE report 18826845 ↗
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- CD HORIZON® Spinal System 5442130Medtronic Sofamor Danek, Inc. · POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION2 reports
- CD HORIZON® Spinal System 7576302Medtronic Sofamor Danek, Inc. · POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION2 reports
- CD HORIZON® Spinal System 7576301Medtronic Sofamor Danek, Inc. · POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION2 reports
- CD HORIZON® Spinal System 54840005535Medtronic Sofamor Danek, Inc. · POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION1 report
- CD HORIZON® Spinal System 75753059Medtronic Sofamor Danek, Inc. · POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION1 report
- CD HORIZON® Spinal System 54840008580Medtronic Sofamor Danek, Inc. · POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.