SIMPLY ICONIC™ Implant 674713NPRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø4.7 x 13 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
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10841307125150), received between Oct 3, 2024 and Sep 29, 2026 — classified as 17 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (9 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 Osseointegrate9
- Positioning Failure6
- Osseointegration Problem2
- Labelling, Instructions for Use or Training Problem1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Inadequate Osseointegration11
- Failure of Implant1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50936512 ↗InjurySep 29, 2026Positioning Failure
Lack of primary stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936143 ↗InjuryJun 4, 2026Positioning Failure; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25400042 ↗InjuryMay 15, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185679 ↗InjuryApr 15, 2026Failure to Osseointegrate
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24889819 ↗InjuryApr 10, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24841056 ↗InjuryMar 26, 2026Failure to Osseointegrate
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24707132 ↗InjuryMar 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24617454 ↗InjuryJan 22, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24147539 ↗InjuryDec 10, 2025Osseointegration Problem; Osseointegration Problem
OSSEOINTEGRATION PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23768809 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474994 ↗InjuryNov 5, 2025Positioning Failure; Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474730 ↗InjuryNov 5, 2025Labelling, Instructions for Use or Training Problem; Failure to Osseointegrate; Labelling, Instructions for Use or Training Problem; Failure to Osseointegrate
HYGIENE AROUND IMPLANT: GOOD; BONE QUALITY: TYPE II (MEDIUM/HARD BONE).
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474688 ↗InjuryNov 4, 2025Positioning Failure; Positioning Failure
InjuryJan 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21184075 ↗InjuryOct 25, 2024Malposition of Device; Malposition of Device
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20538137 ↗InjuryOct 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRODUCT COMPL: FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20362423 ↗
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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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