Simply Iconic™ Implant 673210NPRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.2 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 Implant Direct Simply Iconic dental implant appears in 92 adverse event reports, with no deaths and 91 injuries. Reports mostly describe implants failing to fuse with the bone, with some parts separating or sitting in the wrong position. Listed patient problems include poor bone fusion, abscess and infection. There were 63 reports in the past 12 months, up from 10 in the year 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
- 90
- Deaths reported
- 0
- Injuries reported
- 89
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10841307124955), received between Oct 4, 2023 and Aug 17, 2026 — classified as 89 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (62 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 Osseointegrate62
- Positioning Failure12
- Premature Separation6
- Osseointegration Problem5
- Malposition of Device4
- Adverse Event Without Identified Device or Use Problem3
- Insufficient Device Problem Information2
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration57
- No Clinical Signs, Symptoms or Conditions48
- Failure of Implant19
- Abscess14
- Inflammation4
- Unspecified Infection4
- Implant Pain2
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2026Positioning Failure
Lack of primary stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50288990 ↗InjuryAug 17, 2026Premature Separation
Part not retained on mating Part.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50288737 ↗InjuryAug 17, 2026Premature Separation
Component not retained on mating part.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50284381 ↗InjuryAug 14, 2026Positioning Failure
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50258826 ↗InjuryJul 28, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50062987 ↗InjuryJul 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25707313 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25631364 ↗InjuryJun 17, 2026Positioning Failure; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25538767 ↗InjuryJun 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 25524729 ↗InjuryJun 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 25524728 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 22, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25260454 ↗InjuryMay 13, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25165067 ↗InjuryMay 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25162515 ↗InjuryMay 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25107544 ↗InjuryMay 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25106988 ↗InjuryApr 18, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24920343 ↗MalfunctionApr 14, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24878081 ↗InjuryApr 14, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877460 ↗InjuryApr 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24866372 ↗InjuryApr 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24837294 ↗InjuryApr 2, 2026Positioning Failure; Adverse Event Without Identified Device or Use Problem
TRAUMA / CLINICAL COMPLICATION ONLY.
Patient problems: Bone Fracture(s); Inadequate Osseointegration
MAUDE report 24768960 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24720148 ↗InjuryMar 25, 2026Insufficient Device Problem Information
DROPPED IMPLANT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24692120 ↗
Other Implant, Endosseous, Root-Form devices
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- 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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