SIMPLY ICONIC™ Implant 675208RPRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø5.2 x 8 Platform 3.4mmD (RP) 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 implant has 103 adverse event reports, with no deaths, 102 injuries and 1 malfunction. Reports mostly describe implants failing to osseointegrate, along with positioning or stability problems. There are no recalls naming this device. Reports increased from 23 to 58 between the prior and most recent 12-month periods.
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
- 108
- Deaths reported
- 0
- Injuries reported
- 107
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 10841307125228), received between Feb 16, 2023 and Sep 9, 2026 — classified as 107 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (60 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 Osseointegrate60
- Positioning Failure27
- Osseointegration Problem12
- Adverse Event Without Identified Device or Use Problem5
- Malposition of Device4
- Difficult to Insert3
- Loss of Osseointegration2
- Migration2
Patient problems
- No Clinical Signs, Symptoms or Conditions65
- Inadequate Osseointegration57
- Failure of Implant21
- Unspecified Infection7
- Abscess6
- Inflammation4
- Pain4
- Granuloma3
Recent adverse event reports
The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Positioning Failure; Separation Failure
Lack of Primary Stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693355 ↗InjurySep 9, 2026Positioning Failure; Difficult to Insert
Lack of Primary Stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693063 ↗InjurySep 9, 2026Positioning Failure; Difficult to Insert
Lack of Primary Stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692736 ↗InjurySep 9, 2026Positioning Failure
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692412 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50677592 ↗InjurySep 8, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50677070 ↗InjuryAug 16, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50266327 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of Osseointegration.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50202557 ↗InjuryAug 6, 2026Osseointegration Problem
Primary stability couldn¿t be achieved.
Patient problems: Inadequate Osseointegration
MAUDE report 50158006 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25631371 ↗InjuryJun 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 25488115 ↗InjuryJun 12, 2026Positioning Failure; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25486652 ↗InjuryJun 11, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473618 ↗InjuryJun 10, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25464804 ↗InjuryJun 10, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25464078 ↗InjuryMay 14, 2026Positioning Failure
InjuryMay 14, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25174150 ↗InjuryMay 7, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25118715 ↗InjuryMay 6, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25096837 ↗InjuryMay 5, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086981 ↗InjuryApr 29, 2026Labelling, Instructions for Use or Training Problem
USABILITY - WRONG PART USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028099 ↗InjuryApr 22, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24957711 ↗InjuryApr 17, 2026Positioning Failure; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24916829 ↗InjuryApr 17, 2026Failure to Osseointegrate; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24916822 ↗InjuryApr 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24889825 ↗
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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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