SIMPLY ICONIC™ Implant 674710NPRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø4.7 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 screw-shaped implant anchored into the jawbone to hold a replacement tooth. The 71 reports mostly describe the implant failing to fuse with the bone, so it loses its grip and shifts out of position; others mention swelling, abscess, or the implant breaking. There are no deaths, and all 71 reports describe injuries. No recalls name this device. Reports rose from 14 in the prior 12 months to 43 in the most recent 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
- 71
- Deaths reported
- 0
- Injuries reported
- 71
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10841307125136), received between Jan 22, 2024 and Sep 15, 2026 — classified as 71 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (46 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 Osseointegrate46
- Positioning Failure9
- Malposition of Device5
- Fracture2
- Osseointegration Problem2
- Premature Separation2
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Insert1
Patient problems
- Inadequate Osseointegration47
- No Clinical Signs, Symptoms or Conditions44
- Abscess10
- Failure of Implant7
- Fistula2
- Inflammation2
- Unspecified Infection2
- Osteomyelitis1
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50780406 ↗InjurySep 15, 2026Positioning Failure
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50780391 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50780374 ↗InjuryAug 17, 2026Positioning Failure
Primary stability couldn¿t be achieved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50277175 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
Usability - Wrong part used.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50165883 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50037059 ↗InjuryJun 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 25506125 ↗InjuryJun 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 25505124 ↗InjuryJun 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 25488388 ↗InjuryJun 8, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25435258 ↗InjuryMay 13, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163795 ↗InjuryMay 8, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Fistula; Inadequate Osseointegration
MAUDE report 25128656 ↗InjuryMay 8, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25125961 ↗InjuryApr 30, 2026Fracture
COMPONENT FRACTURED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25048516 ↗InjuryApr 23, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 24971072 ↗InjuryApr 17, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917408 ↗InjuryApr 14, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24879079 ↗InjuryMar 31, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24747898 ↗InjuryMar 23, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24670635 ↗InjuryMar 23, 2026Failure to Osseointegrate
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24664486 ↗InjuryMar 23, 2026Failure to Osseointegrate
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24664011 ↗InjuryMar 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24657103 ↗InjuryMar 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24549030 ↗InjuryFeb 26, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461335 ↗InjuryFeb 19, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24390303 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
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- 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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