SIMPLY ICONIC™ Implant 675710RPRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø5.7 x 10 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 screw placed into the jawbone. Most of the 57 reports describe the implant not fusing properly with the bone or ending up in the wrong position, with reports also mentioning inflammation, pain and an abscess. There are no deaths, 56 injuries and 1 malfunction. No recalls name this device. Reports rose sharply, from 6 in the prior 12 months to 40 in the last 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
- 60
- Deaths reported
- 0
- Injuries reported
- 59
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10841307125280), received between Oct 13, 2022 and Sep 29, 2026 — classified as 59 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (31 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 Osseointegrate31
- Positioning Failure18
- Osseointegration Problem7
- Malposition of Device5
- Difficult to Insert1
- Loss of Osseointegration1
- Material Deformation1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- Inadequate Osseointegration34
- Failure of Implant11
- Inflammation3
- Pain2
- Abscess1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Granuloma1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50938936 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50832768 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50754952 ↗InjuryAug 25, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50440625 ↗InjuryAug 18, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50308018 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50214662 ↗InjuryJul 31, 2026Positioning Failure; Osseointegration Problem
Lack of primary stability.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50105906 ↗InjuryJun 12, 2026Positioning Failure; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25486639 ↗InjuryJun 11, 2026Positioning Failure; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25478332 ↗InjuryJun 11, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473803 ↗InjuryJun 11, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473273 ↗InjuryJun 10, 2026Positioning Failure; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25462939 ↗InjuryJun 8, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428327 ↗InjuryMay 18, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25209285 ↗InjuryMay 14, 2026Difficult to Insert
COMPONENT DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174375 ↗InjuryMay 6, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25097425 ↗InjuryMay 6, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25096295 ↗InjuryMay 5, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25089173 ↗InjuryMay 5, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086919 ↗MalfunctionMay 5, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25086750 ↗InjuryMay 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25070281 ↗InjuryApr 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24916585 ↗InjuryApr 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24889829 ↗InjuryApr 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24859393 ↗InjuryApr 11, 2026Failure to Osseointegrate
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- 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.
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