Simply Iconic™ Implant 673213NPRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.2 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
Quick summary
This Simply Iconic dental implant is a root-form screw placed into the jawbone. Most of the 45 reports describe the implant failing to fuse with the bone, along with difficulty seating it, parts not detaching as expected, and swelling or infection around the site. There are 44 injuries and no deaths, and no recalls name this device. Reports rose from 7 in the earlier12-month period to 26 in the most recent one.
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
- 45
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10841307124979), received between Jul 27, 2022 and Sep 8, 2026 — classified as 44 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (26 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 Osseointegrate26
- Positioning Failure6
- Malposition of Device3
- Separation Failure3
- Difficult to Insert2
- Migration2
- Loss of Osseointegration1
- No Apparent Adverse Event1
Patient problems
- Inadequate Osseointegration25
- No Clinical Signs, Symptoms or Conditions25
- Failure of Implant10
- Inflammation5
- Unspecified Infection4
- Abscess2
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50679310 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50212671 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50202703 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50034860 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50026983 ↗InjuryMay 28, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25320171 ↗InjuryApr 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25052525 ↗InjuryApr 30, 2026Separation Failure
COMPONENT DOES NOT DISENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25049399 ↗InjuryApr 14, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873710 ↗InjuryFeb 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24328129 ↗InjuryFeb 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 24327870 ↗InjuryFeb 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 24261801 ↗InjuryJan 27, 2026Premature Separation
COMPONENT NOT RETAINED ON MATING PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189247 ↗InjuryJan 8, 2026Malposition of Device
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24013013 ↗InjuryJan 8, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 24012994 ↗InjuryJan 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23996729 ↗InjuryJan 5, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 23968231 ↗InjuryDec 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23692924 ↗InjuryNov 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23555069 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23475045 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474976 ↗InjuryNov 5, 2025Malposition of Device; Malposition of Device
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23474468 ↗InjuryNov 5, 2025Migration; Migration
PART MIGRATES.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474290 ↗InjuryNov 5, 2025Positioning Failure; Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474287 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23474193 ↗
Other Implant, Endosseous, Root-Form devices
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- 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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