Reflect Implant System RA4313CRecalls & reported problems
Integrated Dental Systems, LLC · Reflect Rapid 4.3 x 13mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00817773024092), received between Nov 14, 2022 and Jun 26, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3 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
- Failure to Osseointegrate3
- Patient Device Interaction Problem2
- Loss of Osseointegration1
Patient problems
- Failure of Implant6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2025Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 22341007 ↗MalfunctionFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 21462965 ↗MalfunctionJul 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19819522 ↗MalfunctionDec 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18369551 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT (B)(6) RECEIVED IMPLANT (RFLT RAPID RA4313C REFLECT RAPID FIXTURE Ø 4.3MM X 13 L) ON (B)(6) 2021, EXPERIENCED FAILURE TO INTEGRATE AND HAD THE IMPLANT REMOVED ON (B)(6) 2022, X-RAYS WERE PROVIDED. IMPLANT REPLACEMENT WAS SENT TO DR. (B)(6) BURNS ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 15793719 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT (B)(6) RECEIVED IMPLANT (RFLT RAPID RA4313C REFLECT RAPID FIXTURE Ø 4.3MM X 13 L) ON (B)(6) 2022, EXPERIENCED FAILURE TO INTEGRATE AND HAD THE IMPLANT REMOVED ON (B)(6) 2022, X-RAYS NOT PROVIDED. IMPLANT REPLACEMENT WAS SENT TO DR. (B)(6) ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 15791931 ↗
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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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