Neodent 109.913Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · GM TITAMAX IMPLANT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent GM Titamax implant is a screw-shaped device placed into bone during dental surgery. Most of the 314 reports describe the implant failing to bond with the bone, and many mention infection, pain or scar-like tissue build-up. All 314 reports are injury reports, with no deaths, and 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
- 318
- Deaths reported
- 0
- Injuries reported
- 318
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 318 adverse event reports that list this exact device (DI 07899878024026), received between May 3, 2019 and Sep 18, 2026 — classified as 318 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (253 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate253
- Loss of Osseointegration45
- Adverse Event Without Identified Device or Use Problem15
- Difficult to Insert6
Patient problems
- No Clinical Signs, Symptoms or Conditions126
- Unspecified Infection116
- Fibrosis93
- Pain79
- Inflammation30
- Swelling/ Edema22
- Fistula12
- Abscess10
Recent adverse event reports
The 25 most recent of 318 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826945 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50826929 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Abscess; Fibrosis; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Swelling/ Edema
MAUDE report 50826874 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50826845 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Abscess; Pain
MAUDE report 50655936 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. Details of surgery: Primary stability not achieved. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type IV and inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility and Bleeding. No further patient complications were reported.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding
MAUDE report 50285815 ↗InjuryAug 13, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50239939 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 36. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50200188 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 35. On (b)(6) 2026, non-osseointegration was verified. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50200163 ↗InjuryAug 3, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50121538 ↗InjuryJul 31, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 34. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50103779 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2025 in FDI 45. On (B)(6) 2026, non-osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis and Pain. No further patient complications were reported.
Patient problems: Pain; Unspecified Infection
MAUDE report 50044654 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted on (b)(6) 2026 in FDI 47. Details of surgery: Ridge augmentation. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III and fair oral hygiene. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis and Fistula. No further patient complications were reported.
Patient problems: Fistula; Unspecified Infection
MAUDE report 50044431 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in FDI 47. Details of surgery: Implant surface not completely covered with bone. On (b)(6)2026, non-osseointegration was verified. Patient presented with fair oral hygiene. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50023674 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in FDI 35. On (b)(6)2026, non-osseointegration was verified. Patient presented with bone type III and fair oral hygiene. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain and Swelling. No further patient complications were reported.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50023582 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 43. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III and fair oral hygiene. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain and Swelling. No further patient complications were reported.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50023577 ↗InjuryJul 13, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: RIDGE AUGMENTATION. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND FAIR ORAL HYGIENE. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 25802447 ↗InjuryJul 13, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 46. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. 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 25802441 ↗InjuryJul 13, 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 25801793 ↗InjuryJul 10, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 45. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. ON (B)(6) 2026, 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 25786546 ↗InjuryJul 10, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 45. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. ON (B)(6) 2026, 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 25784986 ↗InjuryJul 6, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 15. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND FAIR ORAL HYGIENE. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 25724404 ↗InjuryJul 2, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 47. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 25696025 ↗InjuryJun 22, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION 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 25585010 ↗InjuryJun 8, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 14. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PERI-IMPLANTITIS, PAIN AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 25435004 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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