SIMPLY ICONIC™ Implant 675213RPRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø5.2 x 13 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
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10841307125259), received between Aug 18, 2024 and Aug 14, 2026 — classified as 14 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (6 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 Osseointegrate6
- Malposition of Device3
- Osseointegration Problem2
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Insert1
- No Apparent Adverse Event1
- Positioning Failure1
Patient problems
- Inadequate Osseointegration8
- No Clinical Signs, Symptoms or Conditions7
- Failure of Implant3
- Unspecified Infection2
- Hypersensitivity/Allergic reaction1
- Sinus Perforation1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50260060 ↗InjuryAug 6, 2026Osseointegration Problem
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50166465 ↗InjuryJun 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25642314 ↗InjuryMay 14, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Hypersensitivity/Allergic reaction; Inadequate Osseointegration
MAUDE report 25174560 ↗InjuryApr 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24837910 ↗InjuryMar 31, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24747888 ↗InjuryJan 6, 2026Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23982606 ↗InjuryNov 29, 2025Osseointegration Problem; Osseointegration Problem
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23676837 ↗InjuryMar 27, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21714084 ↗InjuryFeb 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21327768 ↗InjuryDec 5, 2024Malposition of Device; No Apparent Adverse Event; Malposition of Device; No Apparent Adverse Event
InjuryOct 23, 2024Positioning Failure; Positioning Failure
COMPL: PRIMARY STABILITY COULDN'T BE ACH.
Patient problems: Failure of Implant
MAUDE report 20513308 ↗InjuryAug 20, 2024Difficult to Insert; Difficult to Insert
InjuryAug 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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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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