ReActive® Implant 755710Recalls & 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 ReActive® Implant 755710 is a small, root-form dental implant used as an anchor for a replacement tooth. The 60 reports mostly describe the implant failing to fuse with the surrounding jawbone or losing that fusion, along with difficulty getting a stable position during placement;59 reports involved an injury and there were no deaths. There are no recalls naming 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
- 60
- Deaths reported
- 0
- Injuries reported
- 59
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10841307103745), received between Sep 5, 2019 and Apr 13, 2026 — classified as 59 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (28 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 Osseointegrate28
- Positioning Failure9
- Loss of Osseointegration6
- Osseointegration Problem6
- Premature Separation6
- Positioning Problem3
- Component Incompatible2
- Fracture1
Patient problems
- Failure of Implant43
- No Clinical Signs, Symptoms or Conditions13
- Osteopenia/ Osteoporosis12
- Inflammation11
- Inadequate Osseointegration10
- No Consequences Or Impact To Patient6
- Fibrosis4
- Unspecified Infection4
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24861228 ↗InjuryFeb 18, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24383987 ↗InjuryNov 4, 2025Positioning Failure; Osseointegration Problem; Positioning Failure; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23461408 ↗InjuryMar 10, 2025Osseointegration Problem; Osseointegration Problem
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21567895 ↗InjuryFeb 7, 2025Component Incompatible; Component Incompatible
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21338323 ↗InjuryFeb 7, 2025Component Incompatible; Component Incompatible
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21338321 ↗InjurySep 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20217951 ↗InjurySep 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20214765 ↗InjuryApr 23, 2024Osseointegration Problem; Osseointegration Problem
InjuryApr 23, 2024Osseointegration Problem; Osseointegration Problem
InjuryApr 16, 2024Positioning Failure; Positioning Failure
InjuryApr 15, 2024Positioning Failure; Positioning Failure
TRAUMA / CLINICAL COMPLICATION ONLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19110244 ↗InjuryApr 3, 2024Premature Separation; Premature Separation
PART NOT RETAINED ON MATING PART (E.G., DROPPED FROM DRIVER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19035392 ↗InjuryApr 2, 2024Premature Separation; Premature Separation
DROPPED FROM THE IMPLANT DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19027790 ↗InjuryMar 26, 2024Premature Separation; Premature Separation
InjuryMar 26, 2024Premature Separation; Premature Separation
PART NOT RETAINED ON MATING PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18982054 ↗InjuryMar 2, 2024Premature Separation; Premature Separation
PART NOT RETAINED ON MATING PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18823332 ↗InjuryFeb 13, 2024Premature Separation; Premature Separation
COMPL:DROPPED FROM THE IMPLANT DRIVER.
Patient problems: Inadequate Osseointegration
MAUDE report 18698503 ↗InjuryFeb 13, 2024Positioning Failure; Positioning Failure
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: Inadequate Osseointegration
MAUDE report 18698494 ↗InjuryFeb 13, 2024Positioning Failure; Positioning Failure
InjuryFeb 13, 2024Positioning Failure; Positioning Failure
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: Inadequate Osseointegration
MAUDE report 18698492 ↗InjuryJan 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT 203372452, AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 17958048 ↗InjuryOct 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; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 17958046 ↗InjuryOct 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; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 17958038 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
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- 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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