Onyx Implant NM-G3710Recalls & reported problems
Noris Medical Ltd · Onyx, D3.75, L10, Int. Hex Ti. Implant · Class 2 · Implant
All models of Onyx Implant (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290108813081), received between Oct 4, 2023 and Oct 8, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
- Loosening of Implant Not Related to Bone-Ingrowth2
Patient problems
- Failure of Implant2
- Implant Pain2
- Unspecified Infection2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024. ON (B)(6) 2024, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. OBSERVED DURING THE EVENT: INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 20394151 ↗InjuryOct 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024. ON (B)(6) 2024, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. OBSERVED DURING THE EVENT: INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 20394077 ↗MalfunctionOct 4, 2023Fracture; Fracture
FOLLOWING A PATIENT'S COMPLAINT AND AFTER AN EXAMINATION, DOCTOR REPORTED A FRACTURE IN 3 IMPLANTS. THIS REPORT IS 3-LAST OF 3 RELATED TO THIS EVENT.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 17868565 ↗MalfunctionOct 4, 2023Fracture; Fracture
FOLLOWING A PATIENT'S COMPLAINT AND AFTER AN EXAMINATION, DOCTOR REPORTED A FRACTURE IN 3 IMPLANTS. THIS REPORT IS 2 OF 3 RELATED TO THIS EVENT, AND 1 MORE REPORTS ARE ISSUED.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 17868253 ↗
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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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