ReActive® Implant 753710Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Implant Direct ReActive implant is a root-form implant placed into the jawbone. Of its 165 adverse event reports, 161 are injuries and 4 are malfunctions, with no deaths. Most describe the implant not bonding with the bone or losing that bond. Reports also mention low bone density (osteopenia or osteoporosis) and inflammation in patients. Reports fell from 20 in the prior 12 months to 7 in the last 12 months. 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: 165
Deaths reported: 0
Injuries reported: 161
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 10841307103592), received between Feb 24, 2018 and Jun 4, 2026 — classified as 161 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (102 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Osseointegrate102
Loss of Osseointegration17
Component Incompatible14
Osseointegration Problem13
Positioning Failure10
Positioning Problem4
Separation Failure4
Fracture2

Patient problems

Failure of Implant130
Osteopenia/ Osteoporosis47
Inflammation40
No Clinical Signs, Symptoms or Conditions33
Inadequate Osseointegration25
No Consequences Or Impact To Patient13
Insufficient Information12
Unspecified Infection11

Recent adverse event reports

The 25 most recent of 165 reports, in the reporter's own words as published by the FDA.

InjuryJun 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25402757 ↗
InjuryMar 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Bone Fracture(s); Inadequate Osseointegration
MAUDE report 24736196 ↗
InjuryMar 3, 2026Component Incompatible
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503191 ↗
InjuryMar 3, 2026Component Incompatible
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24502289 ↗
InjuryDec 4, 2025Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem; Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem
USABILITY - WRONG PART USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23720371 ↗
InjuryNov 5, 2025Component Incompatible; Component Incompatible
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23474457 ↗
InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23461248 ↗
InjuryOct 31, 2025Component Incompatible; Failure to Osseointegrate; Component Incompatible; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436817 ↗
InjuryOct 31, 2025Component Incompatible; Failure to Osseointegrate; Component Incompatible; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436813 ↗
InjuryOct 31, 2025Component Incompatible; Component Incompatible
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436812 ↗
InjuryOct 31, 2025Component Incompatible; Component Incompatible
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436810 ↗
InjuryOct 31, 2025Component Incompatible; Failure to Osseointegrate; Component Incompatible; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436808 ↗
InjuryOct 31, 2025Component Incompatible; Failure to Osseointegrate; Component Incompatible; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436807 ↗
InjuryOct 31, 2025Component Incompatible; Failure to Osseointegrate; Component Incompatible; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436805 ↗
InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21714097 ↗
InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21714049 ↗
InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21714045 ↗
InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21714042 ↗
InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21714040 ↗
InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21714039 ↗
InjuryFeb 7, 2025Component Incompatible; Component Incompatible
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21338326 ↗
InjuryFeb 7, 2025Component Incompatible; Component Incompatible
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21338319 ↗
InjuryFeb 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21338316 ↗
InjuryFeb 7, 2025Component Incompatible; Component Incompatible
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21338314 ↗
InjuryFeb 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 21338312 ↗

Device details

UDI-DI	`10841307103592`
Brand	ReActive® Implant
Model	753710
Company	Implant Direct Sybron Manufacturing LLC
Product code	DZE · Implant, Endosseous, Root-Form
Class	Class 2
FDA submission	K080633
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 20, 2024

Device type (GMDN): Dental implant system

A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

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All Implant, Endosseous, Root-Form devices →

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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