NOVAE GE007-51Recalls & reported problems
Soc Etudes Recherches Fabrication · 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 03662200012657), received between Jan 24, 2025 and Jan 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Sharp Edges1
Patient problems
- Discomfort1
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2025Fracture; Sharp Edges; Fracture; Sharp Edges
SERF RC-23-0198 FOLLOWING A REPORT OF AN AES BY THE TECHNICIAN DURING A THP OPERATION (INJURY WITH A METAL SPLINTER FROM THE TRIAL CUP), THE OPERATING THEATRE REQUESTED A DEPOSIT EXCHANGE FOR ALL THE TRIAL CUPS AND THE CUP HOLDER IN THE BOX. THE REFERENCES ARE GIVEN BELOW: GE007-45 / GE007-47 / GE007-49 / GE007-51 / GE007-53 / / GE007-55 / GE007-57 / GE007-59 / GE007-61 / EXT007.
Patient problems: Discomfort; Needle Stick/Puncture
MAUDE report 21230585 ↗
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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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