Neodent 140.961Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · GM DRIVE ACQUA IMPLANT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent GM Drive Acqua implant is placed into bone, and all 503 reports are injury reports, mostly describing the bone not bonding with the implant or the implant losing its hold. Reports list pain, infection, tissue damage, and scar-like tissue around the implant. There are no deaths reported, and no recalls name this device. Reports rose to 102 in the past year from 67 in the year before.
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
- 510
- Deaths reported
- 0
- Injuries reported
- 510
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 510 adverse event reports that list this exact device (DI 07899878025061), received between Oct 9, 2018 and Sep 14, 2026 — classified as 510 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (267 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 Osseointegrate267
- Loss of Osseointegration199
- Adverse Event Without Identified Device or Use Problem35
- Fracture7
- Difficult to Insert2
Patient problems
- No Clinical Signs, Symptoms or Conditions257
- Fibrosis131
- Pain92
- Unspecified Infection89
- Tissue Damage62
- Inflammation46
- Hemorrhage/Blood Loss/Bleeding22
- Swelling/ Edema18
Recent adverse event reports
The 25 most recent of 510 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762465 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762464 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762338 ↗InjurySep 14, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in ADA 10. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758035 ↗InjurySep 14, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in ADA 7. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758031 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in ADA 13. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. 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 50757935 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50417707 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 50417231 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50417084 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50413440 ↗InjuryAug 24, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 30. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Pain, Mobility and Swelling. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 50413202 ↗InjuryAug 24, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in ADA 13. 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 50413084 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in FDI 21. On 2026 (b)(6), 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 50200651 ↗InjuryAug 7, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2021 in ADA 4. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50179880 ↗InjuryAug 7, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2021 in ADA 4. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50178563 ↗InjuryAug 6, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50163781 ↗InjuryAug 6, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 10. On (b)(6) 2026, non-osseointegration was verified. Patient presented with fair oral hygiene. 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 50162187 ↗InjuryAug 3, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in ADA 13. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50121903 ↗InjuryAug 3, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2023 in ADA 13. On (B)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50121893 ↗InjuryAug 3, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2025 in ADA 13. On (B)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50118408 ↗InjuryAug 3, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(60 2023 in ADA 13. On (B)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50118391 ↗InjuryJul 31, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in the patient's mouth. On (b)(6)2026, non-osseointegration was verified. Patient presented with fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50103877 ↗InjuryJul 17, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 20. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. 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 25860223 ↗InjuryJul 17, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 20. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. 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 25860153 ↗InjuryJul 17, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 3. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. 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 25860138 ↗
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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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