Neodent 140.585Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · Ti TITAMAX EX ACQUA IMPLANT · 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 07899878016373), received between Nov 9, 2017 and Aug 15, 2022 — classified as 5 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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 Osseointegrate5
Patient problems
- Tissue Damage4
- Unspecified Infection3
- 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.
InjuryAug 15, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 13. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15228107 ↗InjuryJun 29, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) ¿ THE DENTIST REPORTED THAT 1 YEAR AND 2 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage; Unspecified Infection
MAUDE report 7651289 ↗InjuryJun 28, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) ¿ THE DENTIST REPORTED THAT 6 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE III.
Patient problems: Tissue Damage; Unspecified Infection
MAUDE report 7648197 ↗InjuryJun 28, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 4 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE III.
Patient problems: Tissue Damage; Unspecified Infection
MAUDE report 7647643 ↗InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT ALMOST 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #25 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. 35 N.CM. OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage
MAUDE report 7015917 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
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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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