Reflect Implant System RA4311CRecalls & reported problems
Integrated Dental Systems, LLC · Reflect Rapid 4.3 x 11.5mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00817773024085), received between Nov 14, 2022 and Feb 26, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (8 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 Osseointegrate8
- Fracture3
- Patient Device Interaction Problem2
Patient problems
- Failure of Implant13
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Fracture
PATIENT PRESENTED WITH LOOSE IMPLANT CROWN REMOVED PROSTHETIC SCREW AND CROWN REVEALED FRACTURED SEGMENT OF CONICAL CONNECTION.
Patient problems: Failure of Implant
MAUDE report 24454927 ↗MalfunctionJul 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINETGRATE.
Patient problems: Failure of Implant
MAUDE report 19819562 ↗MalfunctionJun 27, 2024Fracture; Fracture
MalfunctionApr 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19065063 ↗MalfunctionMar 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18969105 ↗MalfunctionOct 19, 2023Fracture; Fracture
MalfunctionSep 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17837320 ↗MalfunctionAug 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17645744 ↗MalfunctionAug 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17558544 ↗MalfunctionAug 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTGERATE.
Patient problems: Failure of Implant
MAUDE report 17558535 ↗MalfunctionMay 12, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16923157 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT N DAHER RECEIVED IMPLANT (RFLT RAPID RA4311C REFLECT RAPID FIXTURE Ø4.3MM X 11.5 L) ON (B)(6) 2021 AND EXPERIENCED A FAILURE TO INTEGRATE WHICH LED TO HAVING THE IMPLANT REMOVED ON (B)(6) 2022. X-RAYS WERENOT PROVIDED BY THE DENTIST. IMPLANT REPLACEMENT WAS SENT TO DR. YUDI SUGIONO ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 15793651 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT RANDY F RECEIVED IMPLANT (RFLT RAPID RA4311C REFLECT RAPID FIXTURE Ø4.3MM X 11.5 L) ON (B)(6) 2022. THE IMPLANT LOST INTEGRATION AND FAILED ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 15792291 ↗
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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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