SIMPLY ICONIC™ Implant 674706NPRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø4.7 x 6 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
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10841307125112), received between Apr 25, 2023 and Aug 25, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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 Osseointegrate5
- Difficult to Insert1
- Labelling, Instructions for Use or Training Problem1
- Positioning Failure1
Patient problems
- Inadequate Osseointegration4
- No Clinical Signs, Symptoms or Conditions4
- Failure of Implant2
- Inflammation1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50436704 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50036609 ↗InjuryNov 6, 2025Difficult to Insert; Failure to Osseointegrate; Difficult to Insert; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23483612 ↗InjuryMar 4, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
USABILITY - WRONG PART USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21519125 ↗InjuryDec 31, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 23, 2024Positioning Failure; Positioning Failure
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20054073 ↗InjuryApr 25, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16805206 ↗
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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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