Reflect Implant System RA4310CRecalls & reported problems
Integrated Dental Systems, LLC · Reflect Rapid 4.3 x 10mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00817773024078), received between Nov 14, 2022 and Aug 29, 2025 — classified as 15 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate8
- Fracture5
- Patient Device Interaction Problem2
Patient problems
- Failure of Implant15
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 22923896 ↗MalfunctionSep 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20163229 ↗MalfunctionJul 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19819535 ↗MalfunctionJul 24, 2024Fracture; Fracture
MalfunctionJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19658104 ↗MalfunctionJul 2, 2024Fracture; Fracture
MalfunctionApr 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19193832 ↗MalfunctionApr 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19065058 ↗MalfunctionNov 17, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18159056 ↗MalfunctionOct 19, 2023Fracture; Fracture
MalfunctionAug 16, 2023Fracture; Fracture
IMPLANT FAILED DUE TO FAILURE TO FRACTURE.
Patient problems: Failure of Implant
MAUDE report 17558549 ↗MalfunctionAug 16, 2023Fracture; Fracture
MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT CRAIG FREDERICK RECEIVED IMPLANT (RFLT RAPID RA4310C REFLECT RAPID FIXTURE Ø4.3MM X 10 L) ON (B)(6) 2022, EXPERIENCED FAILURE TO INTEGRATE AND LOSS OF INTEGRATION AND HAD THE IMPLANT 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 15792177 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT J CARSTENS RECEIVED IMPLANT (RFLT RAPID RA5010C REFLECT RAPID FIXTURE Ø5.0MM X 10 L) ON (B)(6) 2022 BUT IT FAILED TO INTEGRATE AND THE IMPLANT WAS REMOVED ON (B)(6) 2022. X-RAYS PROVIDED.
Patient problems: Failure of Implant
MAUDE report 15791992 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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