Neodent 109.162Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07898237566764), received between Apr 20, 2018 and Aug 17, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2 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 Osseointegrate2
- Fracture1
Patient problems
- Tissue Damage2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2023Fracture; Fracture
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6)2004 IN FDI 16. ON (B)(6)2023, FRACTURE OF THE IMPLANT WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17566976 ↗InjuryMay 11, 2018Failure to Osseointegrate; Failure to Osseointegrate
RP 011801 - THE DENTIST REPORTED THAT AFTER 3 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 26#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE III.
Patient problems: Tissue Damage
MAUDE report 7508920 ↗InjuryApr 20, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 7 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE III.
Patient problems: Tissue Damage
MAUDE report 7447778 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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