simply InterActive® Implant 655013URecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
All models of simply InterActive Implant (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct simply InterActive dental implant is a tooth-root replacement placed in the jawbone. All 88 reports are injuries, mostly describing the implant failing to bond with the bone, and some mention infection or inflammation around it. No deaths are listed. Reports rose from 4 in the prior 12 months to 18 in the last 12 months. No recalls name this device.
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
- 88
- Deaths reported
- 0
- Injuries reported
- 88
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 10841307107019), received between Oct 5, 2018 and Aug 6, 2026 — classified as 88 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (52 reports).
4 other recalls cover devices cleared under the same FDA submission (K130572); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate52
- Loss of Osseointegration15
- Osseointegration Problem7
- Positioning Failure7
- Malposition of Device4
- Positioning Problem3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant65
- No Clinical Signs, Symptoms or Conditions18
- Inadequate Osseointegration17
- Unspecified Infection16
- Granuloma15
- Inflammation14
- Fibrosis10
- Osteopenia/ Osteoporosis7
Recent adverse event reports
The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50166090 ↗InjuryJul 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 25707312 ↗InjuryMay 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25164451 ↗InjuryMay 11, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 25139876 ↗InjuryApr 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24864274 ↗InjuryMar 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24735725 ↗InjuryMar 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24547239 ↗InjuryFeb 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24261674 ↗InjuryFeb 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24251794 ↗InjuryJan 22, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24146904 ↗InjuryDec 1, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23680370 ↗InjuryNov 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23675560 ↗InjuryNov 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23594011 ↗InjuryNov 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23532807 ↗InjuryNov 6, 2025Malposition of Device; Malposition of Device
INCORRECT PART USED DUE TO INSUFFIC INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23483718 ↗InjuryNov 6, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23483696 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 23474388 ↗InjuryNov 4, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461299 ↗InjuryOct 30, 2025Positioning Failure; Osseointegration Problem; Positioning Failure; Osseointegration Problem
LACK OF PRIMARY STABILITY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23430078 ↗InjuryMar 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21734602 ↗InjuryMar 11, 2025Positioning Failure; Positioning Failure
LACK OF PRIMARY STABILITY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21579667 ↗InjuryJan 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21096986 ↗InjuryOct 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20474961 ↗InjuryAug 28, 2024Positioning Failure; Positioning Failure
COMPL:PRIMARY STABILITY COULDN¿T BE ACHI.
Patient problems: Failure of Implant
MAUDE report 20089475 ↗InjuryApr 26, 2024Loss of Osseointegration; Loss of Osseointegration
Recalls under the same FDA submission
These recalls involve devices cleared under K130572. One submission often covers many models, so check the product and lot details in each record.
- Z-0363-2020 · Oct 26, 2018 · TerminatedImplant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
- Z-1917-2018 · Mar 14, 2018 · TerminatedImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Produ
- Z-0539-2018 · Jan 23, 2018 · TerminatedImplant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
- Z-2551-2018 · Mar 3, 2017 · TerminatedImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermedia
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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