ANAX™ 5.5 CT SPINAL SYSTEM CT0010Recalls & reported problems
CG MedTech Co.,Ltd. · Class 1
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 08800015999854), received between Apr 27, 2021 and Apr 27, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2021Break; Break
INSERTED THREADS BROKE OFF INTO THE INSERTER, IT IS NOT ABLE TO ADVANCE THE SCREW IN ANYMORE OR REMOVE CAUSE THE THREADS BROKE IN THE SCREW. THE THREADS SEARED OFF INSIDE OF THE SCREW, THE SCREW WAS FINE THE SURGEON JUST WAS NOT ABLE TO ADVANCE THE SCREW ANYMORE NOR WAS HE ABLE TO TAKE IT OUT BECAUSE THE THREADS WERE STILL SCREWED INSIDE THE SCREW HEAD. HE NEEDED TO SCREW A COUPLE MORE TURNS BUT IT WAS OK AND DOWN ENOUGH HE COULD WORK WITH IT. THE BROKEN THREAD LEFT INSIDE OF THE SCREW HEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11735786 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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.
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