SIMPLY ICONIC™ Implant 675206RPRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø5.2 x 6 Platform 3.4mmD (RP) Conical · Class 2 · Implant
All models of SIMPLY ICONIC Implant (39)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Simply Iconic dental implant is a root-form implant placed in the jaw to support dental work. The 25 reports that name its identifier mostly describe implants that did not bond with the bone and became loose, sometimes involving poor positioning or infection, with no deaths and 25 injuries mentioned. No recalls name this device, with 16 reports in the last 12 months compared with 3 in the prior 12 months.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10841307125211), received between Aug 28, 2023 and Sep 17, 2026 — classified as 25 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (17 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 Osseointegrate17
- Positioning Failure5
- Osseointegration Problem2
- Adverse Event Without Identified Device or Use Problem1
- Malposition of Device1
Patient problems
- Inadequate Osseointegration19
- No Clinical Signs, Symptoms or Conditions19
- Unspecified Infection4
- Failure of Implant2
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50803618 ↗InjuryJun 29, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25660890 ↗InjuryJun 9, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446727 ↗InjuryMay 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25184444 ↗InjuryMay 14, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25179313 ↗InjuryMay 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25163186 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 28, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24200712 ↗InjuryDec 19, 2025Osseointegration Problem; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23856873 ↗InjuryNov 5, 2025Positioning Failure; Positioning Failure
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23475041 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474488 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23462899 ↗InjuryNov 4, 2025Positioning Failure; Osseointegration Problem; Positioning Failure; Osseointegration Problem
LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23461498 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23461364 ↗InjuryNov 4, 2025Positioning Failure; Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23461278 ↗InjuryNov 4, 2025Malposition of Device; Malposition of Device
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461277 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23385089 ↗InjuryJan 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21211909 ↗InjurySep 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20326923 ↗InjurySep 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20325359 ↗InjurySep 11, 2024Positioning Failure; Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20193759 ↗InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19967271 ↗InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19966950 ↗InjuryAug 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17630830 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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