Reflect Implant System RA5085CRecalls & reported problems
Integrated Dental Systems, LLC · Reflect Rapid 5.0 x 8.5mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00817773024115), received between Nov 14, 2022 and Apr 8, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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
- Failure to Osseointegrate2
- Patient Device Interaction Problem2
Patient problems
- Failure of Implant4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19065077 ↗MalfunctionAug 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17645754 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT L HAGER RECEIVED IMPLANT (RFLT RAPID RA5085C REFLECT RAPID FIXTURE Ø5.0MM X 8.5 L) ON (B)(6) 2022, EXPERIENCED BONE LOSS, FAILURE TO INTEGRATE, PAIN AND/OR INFECTION. THE IMPLANT WAS REMOVED ON (B)(6) 2022, X-RAYS WERE PROVIDED. AN IMPLANT REPLECEMENT WAS SENT TO DR. ANDREW GLENN ON (B)(6) 2022
Patient problems: Failure of Implant
MAUDE report 15792157 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT (B)(6) HAD IMPLANT (RFLT RAPID RA5085C REFLECT RAPID FIXTURE Ø5.0MM X 8.5 L) ON (B)(6) 2022 AND EXPERIENCE A FAILURE TO INTEGRATE ON (B)(6) 2022. A REPLACEMENT IMPLANT WAS SENT TO DR. (B)(6).
Patient problems: Failure of Implant
MAUDE report 15791196 ↗
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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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