ZYFUSE 147.541SRecalls & reported problems
Globus Medical, Inc. · ZyFuse HA Compression Screw, 5mm x 40mm, with Washer · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00889095334111), received between Mar 5, 2024 and Mar 5, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THERE WAS A REVISION SURGERY TO REPLACE A ZYFUSE HA COMPRESSION SCREW THAT WAS BROKEN AT L4/L5 POST OPERATIVELY. THIS EVENT OCCURRED IN THE UNITED KINGDOM.
Patient problems: Insufficient Information
MAUDE report 18834286 ↗
Other SYSTEM, FACET SCREW SPINAL DEVICE devices
- Zyfix Spinal Facet Screw System X076-0020Xtant Medical Holdings, Inc. · SYSTEM, FACET SCREW SPINAL DEVICE1 report
- VIPER 175710130Medos International Sàrl · SYSTEM, FACET SCREW SPINAL DEVICE1 report
- 4.5mm BONE-LOK PLS Implant LSW-45-4555Interventional Spine, Inc · System, Facet Screw Spinal Device1 report
- CORRIDOR 148.540Globus Medical, Inc. · SYSTEM, FACET SCREW SPINAL DEVICE1 report
- VIPER 175710535Medos International Sàrl · SYSTEM, FACET SCREW SPINAL DEVICE1 report
- ION 55 Facet Implant - Sterile TI-K-55Surgentec, LLC · System, Facet Screw Spinal Device1 report
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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