simply InterActive® Implant 653208URecalls & 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 has 108 reports, no deaths and 107 injuries. Most reports describe the implant failing to bond with the jawbone, with some describing bone bonding that was lost, poor stability during placement, or an abutment that is partly visible. Many patients were reported to have implant failure, and some also had low bone density or inflammation. 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
- 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 10841307106807), received between Jun 20, 2018 and Jul 29, 2026 — classified as 107 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (62 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 Osseointegrate62
- Loss of Osseointegration20
- Osseointegration Problem9
- Positioning Failure5
- Positioning Problem5
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- Failure of Implant90
- Osteopenia/ Osteoporosis24
- Inflammation18
- Inadequate Osseointegration13
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient12
- Pain10
- Unspecified Infection10
Recent adverse event reports
The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50073918 ↗InjuryJul 29, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50073658 ↗InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25600399 ↗InjuryApr 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24835944 ↗InjuryFeb 17, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366149 ↗InjuryFeb 3, 2026Inadequacy of Device Shape and/or Size
IMPLANT/ABUTMENT PARTIALLY VISIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251656 ↗InjuryJan 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 24133156 ↗InjuryDec 22, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23872637 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23448940 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Pain
MAUDE report 23436711 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436627 ↗InjuryJan 30, 2025Positioning Failure; Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21278010 ↗InjuryJan 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21051441 ↗InjuryDec 3, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20836654 ↗InjuryAug 7, 2024Failure to Osseointegrate; Malposition of Device; Failure to Osseointegrate; Malposition of Device
FAILURE TO OSSEOINTEGRATE.
Patient problems: Hypersensitivity/Allergic reaction; Inadequate Osseointegration
MAUDE report 19930654 ↗InjuryAug 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
CUSTOMER STATES "OTHER PRODUCT DEFICIENCIES AND TECHNICAL," CUSTOMER CLAIM INDICATES AN ALLERGIC REACTION BY THE PATIENT.
Patient problems: Numbness; Pain
MAUDE report 19929840 ↗InjuryAug 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
CUSTOMER STATES "OTHER PRODUCT DEFICIENCIES AND TECHNICAL", CUSTOMER CLAIM INDICATES, FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19929650 ↗InjuryJun 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 9, 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; Inflammation
MAUDE report 17491736 ↗InjuryAug 4, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 17459220 ↗InjuryJul 18, 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; Granuloma; Wound Dehiscence
MAUDE report 17344537 ↗InjuryJun 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(6) AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 17222460 ↗
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
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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