Reflect Implant System RC3411CRecalls & reported problems
Integrated Dental Systems, LLC · Reflect Certus 3.4x11.5 · 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 00817773022036), received between Nov 14, 2022 and Nov 14, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT (B)(6) RECEIVED IMPLANT (RFLT PRECISE RC3411C REFLECT PRECISE FIXTURE Ø3.4MM X 11.5 L) ON (B)(6) 2022 AND EXPERIENCED BONE LOSS, FAILURE TO INTEGRATE WHICH LED TO LOSS OF INTEGRATION AND HAD THE IMPLANT REMOVED ON (B)(6) 2022 . X-RAYS WERE NOT PROVIDED BY THE DENTIS. IMPLANT REPLACEMENT WAS SENT TO DR. (B)(6) ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 15792002 ↗
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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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