Neodent 109.806Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · TITAMAX SMART IMPLANT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07899878000150), received between Nov 9, 2017 and Apr 23, 2020 — classified as 4 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3 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.
Most reported problems
Device problems
- Failure to Osseointegrate3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Tissue Damage4
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2020Failure to Osseointegrate; Failure to Osseointegrate
(B)(4)¿ THE DENTIST REPORTED THAT 2 MONTHS AND 9 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 11#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE II).
Patient problems: Tissue Damage
MAUDE report 9990545 ↗InjuryAug 15, 2019Failure to Osseointegrate; Failure to Osseointegrate
1000402150: THE DENTIST REPORTED THAT AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON- OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage
MAUDE report 8897941 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
RP.005547 - THE DENTIST REPORTED THAT, 20 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #9, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE II AND BONE GRAFT WAS EXECUTED.
Patient problems: Tissue Damage; Unspecified Infection
MAUDE report 7021456 ↗InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(4) - THE DENTIST REPORTED THAT HE DECIDED TO REMOVE THE DENTAL IMPLANT AT THE INSTALLATION SURGERY, BECAUSE IT WAS DRILLED A LITTLE BIT MORE THAN THE DESIRED. THE IMPLANT WAS NOT REPLACED AT THE SAME SURGERY.
Patient problems: Tissue Damage
MAUDE report 7012926 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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