GoDirect Mini ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls
- 0
We found 8 models of GoDirect Mini Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2019 and Jun 3, 2022 — classified as 22 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (12 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
Most reported GoDirect Mini Implant problems
Device problems
- Failure to Osseointegrate12
- Loss of Osseointegration7
- Fracture2
- Material Fragmentation1
- Osseointegration Problem1
Patient problems
- Failure of Implant22
- Osteopenia/ Osteoporosis7
- Inflammation6
- No Consequences Or Impact To Patient5
- No Information4
- Pain4
- Unspecified Infection2
- Fibromyositis1
GoDirect Mini Implant models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GoDirect® Mini Implant 433010-MImplant, Endosseous, Root-Form5 reports
- 5 reports
- 4 reports
- GoDirect® Mini Implant 423010-MImplant, Endosseous, Root-Form2 reports
- GoDirect® Mini Implant 433011-MImplant, Endosseous, Root-Form2 reports
- 2 reports
- GoDirect® Mini Implant 433013-MImplant, Endosseous, Root-Form1 report
- 1 report
Recent GoDirect Mini Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 3, 2022Fracture; Fracture
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 14599115 ↗InjuryMay 14, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING ROUTINE EXAMINATION, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Pain
MAUDE report 11824015 ↗InjuryOct 7, 2020Osseointegration Problem; Osseointegration Problem
PER (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 10642489 ↗InjuryJul 28, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. THERE WAS NO PATIENT IMPACT NOTED.
Patient problems: Failure of Implant; No Information
MAUDE report 10336030 ↗InjuryJul 28, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. THERE WAS NO PATIENT IMPACT NOTED.
Patient problems: Failure of Implant; No Information
MAUDE report 10336028 ↗InjuryJul 28, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. THERE WAS NO PATIENT IMPACT NOTED.
Patient problems: Failure of Implant; No Information
MAUDE report 10336027 ↗InjuryJul 28, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. THERE WAS NO PATIENT IMPACT NOTED.
Patient problems: Failure of Implant; No Information
MAUDE report 10336026 ↗InjuryFeb 14, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 9710659 ↗InjuryJan 10, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 9575204 ↗InjuryJan 3, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), A PATIENT EXPERIENCED IMPLANT LOSS OF INTEGRATION. PER THE COMPLAINT, THE PATIENT REMOVED THEIR UPPER DENTURE FOR CLEANING AND WHEN PLACING IT BACK, EXPERIENCED SEVERE PAIN. WHEN THE PATIENT RETURNED TO THE CLINIC, IMPLANT MOBILITY WAS NOTED, AND THE IMPLANT WAS REMOVED.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Pain
MAUDE report 9549461 ↗InjuryJan 3, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), A PATIENT EXPERIENCED IMPLANT LOSS OF INTEGRATION.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 9549428 ↗InjuryNov 21, 2019Failure 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; Pain; Unspecified Infection
MAUDE report 9351912 ↗InjuryNov 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9313698 ↗InjuryOct 18, 2019Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 9207966 ↗InjuryOct 8, 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 9165067 ↗
Other Implant Direct Sybron Manufacturing LLC products
- Legacy3 Implant75 models · 9,801 reports
- Legacy2 Implant78 models · 8,257 reports · 2 recalls
- simply InterActive Implant23 models · 4,946 reports
- 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
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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