Neodent 109.143Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · TITAMAX IMPLANT WITH MOUNT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07898237566689), received between Nov 10, 2017 and Sep 28, 2026 — classified as 5 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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate3
- Fracture1
- Loss of Osseointegration1
Patient problems
- Tissue Damage2
- Complaint, Ill-Defined1
- Fibrosis1
- Fistula1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922963 ↗InjuryOct 29, 2021Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2010 IN FDI 31. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2020, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY AND FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Fistula
MAUDE report 12717423 ↗InjuryNov 14, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THE LOSS OF THE DENTAL IMPLANT, BUT DID NOT PROVIDE INFORMATION ABOUT THE CASE.
Patient problems: Complaint, Ill-Defined
MAUDE report 7030544 ↗InjuryNov 10, 2017Fracture; Fracture
(B)(4) - THE DENTIST REPORTED THAT, AROUND 8 YEARS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #13, ITS FRACTURE WAS OBSERVED.
Patient problems: Tissue Damage
MAUDE report 7021777 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #28, IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. FIFTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED BONE TYPE I.
Patient problems: Tissue Damage
MAUDE report 7017384 ↗
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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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