Neodent 140.1059Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · GM HELIX ACQUA IMPLANT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent GM Helix Acqua dental implant is a screw-shaped root-form implant used to replace missing teeth. The 57 reports mostly describe the implant failing to bond with the surrounding jawbone, with some also mentioning infection, pain, inflammation, fistula or loss of the bone bond already achieved. All 57 reports involved injuries, and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 57
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 07899878044512), received between Jan 3, 2023 and Sep 7, 2026 — classified as 57 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (40 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate40
- Adverse Event Without Identified Device or Use Problem15
- Loss of Osseointegration2
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- Unspecified Infection9
- Pain6
- Fibrosis4
- Inflammation4
- Fistula2
- Hemorrhage/Blood Loss/Bleeding2
- Sinus Perforation1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50655507 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in the patient's mouth, failure occurred upon insertion. No product was returned to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50121195 ↗InjuryMay 29, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 19. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PERI-IMPLANTITIS AND FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fistula; Unspecified Infection
MAUDE report 25336621 ↗InjuryMay 29, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 19. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PERI-IMPLANTITIS AND FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fistula; Unspecified Infection
MAUDE report 25335129 ↗InjuryMay 15, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 2. ON (B)(6) 2026 NON-OSSEOINTEGRATION WAS VERIFIED. 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 25190749 ↗InjuryMay 15, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 2. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. 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 25188061 ↗InjuryMay 6, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 36. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation; Pain
MAUDE report 25103132 ↗InjuryApr 13, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 14. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. 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 24864622 ↗InjuryApr 13, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 14. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. 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 24861777 ↗InjuryMar 20, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain
MAUDE report 24653320 ↗InjuryMar 6, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 17. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24535981 ↗InjuryMar 6, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 18. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND INADEQUATE BONE QUALITY/QUANTITY. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24535976 ↗InjuryMar 6, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 24535665 ↗InjuryMar 3, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 24499660 ↗InjuryFeb 9, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 19. DETAILS OF SURGERY: RIDGE AUGMENTATION. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, MOBILITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Inflammation; Unspecified Infection
MAUDE report 24297989 ↗InjuryFeb 9, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 19. DETAILS OF SURGERY: RIDGE AUGMENTATION. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, MOBILITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Inflammation; Unspecified Infection
MAUDE report 24294372 ↗InjuryFeb 2, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 19. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. 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 24239569 ↗InjuryFeb 2, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 19. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. 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 24236775 ↗InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN ADA 14, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED, IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE AND IMMEDIATE EXTRACTION SITE. 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 24110803 ↗InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN ADA 14, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED, IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE AND IMMEDIATE EXTRACTION SITE. 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 24109594 ↗InjuryJan 9, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. 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 24026359 ↗InjuryJan 9, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6)2025 IN ADA 20. ON (B)(6)2025, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24026070 ↗InjuryJan 9, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 20. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24024478 ↗InjuryDec 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 36. DETAILS OF SURGERY: BONE OVERHEATING AND IMMEDIATE EXTRACTION SITE. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Swelling/ Edema
MAUDE report 23870383 ↗InjuryOct 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 23341044 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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