InterActive® Implant 655006Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø5.0 x 6 Platform 3.4mmD (RP) Conical · Implant
All models of InterActive Implant (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10841307100492), received between Jul 23, 2018 and Sep 9, 2024 — classified as 18 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (13 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 Osseointegrate13
- Loss of Osseointegration3
- Positioning Problem1
- Separation Failure1
Patient problems
- Failure of Implant17
- No Consequences Or Impact To Patient5
- No Information2
- Pain2
- Fibrosis1
- Granuloma1
- Inadequate Osseointegration1
- Inflammation1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20173363 ↗InjuryJun 29, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis; Inflammation; Osteopenia/ Osteoporosis; Pain; Unspecified Infection
MAUDE report 14854045 ↗InjuryOct 27, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12704214 ↗InjuryAug 26, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12370436 ↗InjuryAug 5, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Granuloma
MAUDE report 12279955 ↗InjuryMay 5, 2021Failure 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 11777316 ↗InjuryMar 5, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11419831 ↗InjuryOct 23, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 10725554 ↗InjuryJul 7, 2020Failure to Osseointegrate; Failure to Osseointegrate
AS PER COMPLAINT (B)(4) DURING A CLINICAL PROCEDURE A DENTAL IMPLANT DISPLAYED A FAILURE OF OSSEOINTEGRATION AND THE IMPLANT WAS EXPLANTED.
Patient problems: Failure of Implant; Local Reaction
MAUDE report 10240218 ↗InjuryMar 27, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Information
MAUDE report 9887555 ↗InjuryJan 9, 2020Separation Failure; Separation Failure
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, THE COMPONENTS COULD NOT BE SEPARATED.
Patient problems: Failure of Implant; Pain
MAUDE report 9568174 ↗InjuryDec 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE,PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9465228 ↗InjurySep 19, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9085999 ↗InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Information
MAUDE report 8987096 ↗InjurySep 10, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT: (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE. IMPLANT WAS SPINNING DURING TORQUE ABUTMENT.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8979557 ↗InjurySep 9, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT MANUALLY REMOVED THE IMPLANT AND REPORTED ON THE NEXT DAY.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8976619 ↗InjurySep 5, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, IT WAS OBSERVED THAT THE IMPLANT WAS MOBILE AND HAD TO BE REMOVED.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8963724 ↗InjuryJul 23, 2018Positioning Problem; Positioning Problem
PER THE COMPLAINT, THE IMPLANT PASSED THROUGH THE SINUS.
Patient problems: Failure of Implant; Sinus Perforation
MAUDE report 7711861 ↗
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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