Simply Iconic™ Implant 673710NPRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 10 Platform 3.0mmD (NP) 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 device placed into the jawbone. Most of the 182 reports describe the implant failing to bond with the bone, and the reports include 180 injuries and no deaths. Reports from the last 12 months number 103, compared with 27 in the 12 months before. No recalls name this device.
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
- 181
- Deaths reported
- 0
- Injuries reported
- 179
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 181 adverse event reports that list this exact device (DI 10841307125013), received between Sep 23, 2022 and Sep 14, 2026 — classified as 179 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (117 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 Osseointegrate117
- Positioning Failure21
- Labelling, Instructions for Use or Training Problem11
- Malposition of Device9
- Loss of Osseointegration7
- Osseointegration Problem6
- Premature Separation5
- Difficult to Insert3
Patient problems
- Inadequate Osseointegration104
- No Clinical Signs, Symptoms or Conditions96
- Failure of Implant40
- Unspecified Infection20
- Inflammation12
- Osteopenia/ Osteoporosis8
- Abscess7
- Pain6
Recent adverse event reports
The 25 most recent of 181 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50754510 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50741808 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50741807 ↗InjurySep 11, 2026Positioning Failure
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733591 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50679525 ↗InjurySep 3, 2026Failure to Osseointegrate
Failure to osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50589759 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 50476221 ↗InjuryAug 17, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50286458 ↗InjuryAug 17, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 50277654 ↗InjuryAug 17, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50276548 ↗InjuryAug 7, 2026Failure to Osseointegrate
failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50179207 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Fibrosis; Inadequate Osseointegration
MAUDE report 50018757 ↗InjuryJul 27, 2026Loss of Osseointegration
Failure of osseointegration.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50012902 ↗InjuryJul 27, 2026Loss of Osseointegration
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 50012062 ↗InjuryJul 27, 2026Loss of Osseointegration
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 50011856 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50011789 ↗InjuryJul 9, 2026Failure to Osseointegrate; Separation Failure
FAILURE TO OSSEOINTEGRATE
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 25771416 ↗InjuryJul 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25765303 ↗InjuryJun 29, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 25658547 ↗InjuryJun 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25642296 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25628343 ↗InjuryJun 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25509731 ↗InjuryJun 4, 2026Positioning Failure; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25394886 ↗InjuryMay 21, 2026Labelling, Instructions for Use or Training Problem
USABILITY - WRONG PART USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25249776 ↗InjuryMay 18, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25209966 ↗
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.
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