ASPIRON™ S ACP SYSTEM FCA2049Recalls & reported problems
CG MedTech Co.,Ltd. · Class 2 · Implant
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 08800037503824), received between Jul 22, 2020 and Jul 22, 2020 — 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 Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2020Break; Break
THIS IS AN ADVERSE EVENT OCCURED IN THE UNITED STATES ON (B)(6) 2020. DURING THE SURGERY WITH THE ASPERONS ACP SYSTEM (FCA2049), THE SCREW PULLED THROUGH THE PLATE. THE PLATE WAS IMMEDIATELY REMOVED FROM THE PATIENT AND REPLACED WITH A SAME SIZE PRODUCT TO COMPLETE THE OPERATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10312000 ↗
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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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