Reflect Implant System RA3510CRecalls & reported problems
Integrated Dental Systems, LLC · Reflect Rapid 3.5 x 10mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Reflect dental implant is a root-form implant placed in the jawbone. The 26 reports mostly describe implants failing — either breaking or not fusing with the surrounding bone, requiring the implant to fail. There are no deaths and no injuries. No recalls name this device. Reporting has stayed steady, with 1 report in each of the last two 12-month periods.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00817773024023), received between Nov 14, 2022 and Jun 3, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Fracture” (12 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
- Fracture12
- Failure to Osseointegrate9
- Patient Device Interaction Problem3
- Loss of Osseointegration2
Patient problems
- Failure of Implant26
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2026Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 25381100 ↗MalfunctionMar 6, 2025Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 21540543 ↗MalfunctionJul 24, 2024Fracture; Fracture
MalfunctionJul 24, 2024Fracture; Fracture
MalfunctionJul 2, 2024Fracture; Fracture
MalfunctionJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19658099 ↗MalfunctionJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19658098 ↗MalfunctionJan 9, 2024Fracture; Fracture
MalfunctionNov 17, 2023Fracture; Fracture
MalfunctionNov 17, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18159053 ↗MalfunctionOct 19, 2023Fracture; Fracture
MalfunctionOct 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17967290 ↗MalfunctionOct 19, 2023Fracture; Fracture
MalfunctionOct 19, 2023Fracture; Fracture
MalfunctionAug 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17645753 ↗MalfunctionAug 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17558547 ↗MalfunctionAug 16, 2023Fracture; Fracture
MalfunctionAug 16, 2023Fracture; Fracture
MalfunctionAug 16, 2023Fracture; Fracture
MalfunctionAug 16, 2023Fracture; Fracture
IMPLANT FAILED DUE TO FAILURE TO FRACTURE.
Patient problems: Failure of Implant
MAUDE report 17558542 ↗MalfunctionAug 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17558538 ↗MalfunctionAug 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17558533 ↗MalfunctionAug 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17558531 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT P SUKHRAM RECEIVED IMPLANT (RFLT RAPID RA3510C REFLECT RAPID FIXTURE Ø3.5MM X 10 L) ON (B)(6) 2022, EXPERIENCED FAILURE TO INTEGRATE, PAIN AND/OR INFECTION 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 15792755 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
DR. MARKED SPINNER BUT DUE TO THE TIME OF APPLICATION AND REMOVAL BEING YEARS APART, COMPLAINT FALLS INTO LOSS OF INTEGRATION. PATIENT D DAUGHERTY RECEIVED IMPLANT (RFLT RAPID RA3510C REFLECT RAPID FIXTURE Ø3.5MM X 10 L) ON (B)(6) 2020, EXPERIENCED LOSS OF INTEGRATION AND HAD THE IMPLANT REMOVED ON (B)(6) 2022, X-RAYS WERE PROVIDED. IMPLANT REPLACEMENT WAS SENT TO TETON ORAL SURGERY ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 15792102 ↗
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page