simply InterActive ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 23 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,946
- Deaths reported
- 0
- Injuries reported
- 4,901
- Recalls
- 0
We found 23 models of simply InterActive Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 4,946 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2018 and Sep 30, 2026 — classified as 4,901 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3,148 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported simply InterActive Implant problems
Device problems
- Failure to Osseointegrate3,148
- Loss of Osseointegration598
- Positioning Failure462
- Osseointegration Problem300
- Positioning Problem259
- Adverse Event Without Identified Device or Use Problem41
- Separation Failure27
- Fracture23
Patient problems
- Failure of Implant3,942
- Osteopenia/ Osteoporosis878
- Inadequate Osseointegration863
- Unspecified Infection759
- Inflammation750
- No Clinical Signs, Symptoms or Conditions629
- Granuloma520
- Pain516
simply InterActive Implant models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- simply InterActive® Implant 654310UImplant, Endosseous, Root-Form645 reports
- simply InterActive® Implant 655010UImplant, Endosseous, Root-Form498 reports
- simply InterActive® Implant 653710UImplant, Endosseous, Root-Form408 reports
- simply InterActive® Implant 654311UImplant, Endosseous, Root-Form378 reports
- simply InterActive® Implant 655008UImplant, Endosseous, Root-Form343 reports
- simply InterActive® Implant 653711UImplant, Endosseous, Root-Form333 reports
- simply InterActive® Implant 654308UImplant, Endosseous, Root-Form328 reports
- simply InterActive® Implant 654313UImplant, Endosseous, Root-Form288 reports
- simply InterActive® Implant 653210UImplant, Endosseous, Root-Form279 reports
- simply InterActive® Implant 653713UImplant, Endosseous, Root-Form230 reports
- simply InterActive® Implant 655011UImplant, Endosseous, Root-Form221 reports
- simply InterActive® Implant 653708UImplant, Endosseous, Root-Form175 reports
- simply InterActive® Implant 653211UImplant, Endosseous, Root-Form172 reports
- simply InterActive® Implant 653213UImplant, Endosseous, Root-Form126 reports
- simply InterActive® Implant 653208UImplant, Endosseous, Root-Form108 reports
- simply InterActive® Implant 655013UImplant, Endosseous, Root-Form88 reports
- simply InterActive® Implant 654306UImplant, Endosseous, Root-Form80 reports
- simply InterActive® Implant 655006UImplant, Endosseous, Root-Form78 reports
- simply InterActive® Implant 653706UImplant, Endosseous, Root-Form55 reports
- simply InterActive® Implant 654316UImplant, Endosseous, Root-Form41 reports
- simply InterActive® Implant 653716UImplant, Endosseous, Root-Form40 reports
- simply InterActive® Implant 655016UImplant, Endosseous, Root-Form19 reports
- simply InterActive® Implant 653216UImplant, Endosseous, Root-Form13 reports
Recent simply InterActive Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50952898 ↗InjurySep 29, 2026Positioning Failure; Adverse Event Without Identified Device or Use Problem
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50938948 ↗InjurySep 29, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Aspiration/Inhalation; Inadequate Osseointegration
MAUDE report 50937710 ↗InjurySep 29, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50934143 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50923516 ↗InjurySep 28, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50923423 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50920095 ↗InjurySep 28, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919219 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50831146 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50831083 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50829746 ↗InjurySep 17, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 50803896 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50780427 ↗InjurySep 14, 2026Failure to Osseointegrate; Osseointegration Problem
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50764352 ↗InjurySep 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734540 ↗
Other Implant Direct Sybron Manufacturing LLC products
- Legacy3 Implant75 models · 9,801 reports
- Legacy2 Implant78 models · 8,257 reports · 2 recalls
- simply Legacy2 Implant38 models · 3,319 reports
- RePlant Implant20 models · 2,351 reports
- SIMPLY ICONIC Implant39 models · 2,189 reports
- Legacy4 Implant58 models · 1,786 reports
- Legacy1 Implant27 models · 1,635 reports
- InterActive Implant23 models · 1,609 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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