simply InterActive® Implant 655006URecalls & 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 Simply InterActive dental implant. Reports mostly describe failure to osseointegrate, sometimes with positioning problems, inflammation or infection; there are 77 reports that name it, with no deaths and 75 injuries. No recalls name this device, and reports rose from 2 to 8 year over year.
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
- 78
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10841307106975), received between Apr 25, 2019 and Sep 28, 2026 — classified as 76 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (47 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 Osseointegrate47
- Loss of Osseointegration12
- Positioning Failure9
- Positioning Problem4
- Fracture2
- Osseointegration Problem2
- Adverse Event Without Identified Device or Use Problem1
- Difficult or Delayed Separation1
Patient problems
- Failure of Implant68
- Inflammation22
- Unspecified Infection14
- Granuloma10
- Fibrosis9
- Inadequate Osseointegration8
- No Clinical Signs, Symptoms or Conditions7
- Osteopenia/ Osteoporosis5
Recent adverse event reports
The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50920095 ↗InjuryApr 27, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25009688 ↗InjuryApr 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24831916 ↗InjuryApr 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 24818084 ↗InjuryMar 6, 2026Loss of Osseointegration
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24536547 ↗InjuryFeb 27, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24470396 ↗InjuryDec 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23795329 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 23463047 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23463046 ↗InjuryOct 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 23436840 ↗InjuryJan 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryApr 30, 2024Migration; Migration
InjuryNov 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 13, 2023Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17932374 ↗InjuryAug 22, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 17593139 ↗InjuryAug 22, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 17593138 ↗InjuryJul 21, 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
MAUDE report 17373465 ↗InjuryJun 29, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 17227084 ↗InjuryMay 2, 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; Pain
MAUDE report 16854808 ↗InjuryFeb 28, 2023Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16453724 ↗InjuryFeb 20, 2023Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 16403133 ↗InjuryFeb 15, 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; Insufficient Information
MAUDE report 16377864 ↗InjuryFeb 3, 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
MAUDE report 16288942 ↗InjuryJan 24, 2023Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 16234529 ↗InjuryJan 24, 2023Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 16234523 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page