ReActive® Implant 754710Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
All models of ReActive Implant (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct ReActive dental implant, a screw-shaped post placed in the jawbone to hold a tooth replacement, has 117 adverse event reports on file. Most describe the implant failing to fuse with the jawbone, and some mention inflammation, infection or lack of initial stability. The reports include no deaths and 115 injuries, and 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
- 117
- Deaths reported
- 0
- Injuries reported
- 115
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 10841307103691), received between Aug 8, 2019 and Mar 3, 2026 — classified as 115 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (81 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate81
- Loss of Osseointegration14
- Positioning Failure10
- Osseointegration Problem4
- Component Incompatible3
- Positioning Problem3
- Defective Device1
- Malposition of Device1
Patient problems
- Failure of Implant108
- Inflammation17
- Osteopenia/ Osteoporosis17
- No Consequences Or Impact To Patient13
- Unspecified Infection13
- Granuloma11
- Fibrosis9
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2026Component Incompatible
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503463 ↗InjuryMar 3, 2026Component Incompatible
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503379 ↗InjuryMar 3, 2026Component Incompatible
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503295 ↗InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21767852 ↗InjuryMar 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21734598 ↗InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21714035 ↗InjuryNov 22, 2024Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20763897 ↗InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20337538 ↗InjurySep 13, 2024Positioning Failure; Positioning Failure
COMPONENT NOT RETAINED ON MATING PART.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20215661 ↗InjurySep 10, 2024Positioning Failure; Positioning Failure
COMPL: PRIMARY STABILITY COULDN¿T BE ACHI.
Patient problems: Failure of Implant
MAUDE report 20183918 ↗InjuryApr 23, 2024Osseointegration Problem; Osseointegration Problem
InjuryApr 23, 2024Osseointegration Problem; Osseointegration Problem
InjuryApr 23, 2024Osseointegration Problem; Osseointegration Problem
InjuryApr 23, 2024Osseointegration Problem; Osseointegration Problem
InjuryApr 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 19091392 ↗InjuryApr 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 19091292 ↗InjuryNov 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis; Foreign Body Reaction; Osteopenia/ Osteoporosis
MAUDE report 18226991 ↗InjuryOct 31, 2023Defective Device; Defective Device
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PACKAGING WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 18038205 ↗InjuryOct 26, 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 18008790 ↗
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- 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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