Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. TI TITAMAX EX IMPLANT (4.1)3.75X17 MM; ENDOSSEOUS DENTAL IMPLANT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NEODENT - JJGC S.A. TI TITAMAX EX IMPLANT (4.1)3.75X17 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.586
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Unspecified Infection (1930); Tissue Damage (2104)
Date of Event 01/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.It was not possible to track the lot number because the system used in that time is not used anymore.
 
Event or Problem Description
(b)(4) ¿ the dentist reported that after dental implant was installed in intraoral region 6#, its loss of osseointegration was observed.In addition, the patient presented peri-implantitis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TI TITAMAX EX IMPLANT (4.1)3.75X17 MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NEODENT - JJGC S.A.
av. juscelino kubitschek de
oliveira, 3291 cic
curitiba PR 81270 -200
BR  81270-200
MDR Report Key7840969
Report Number3008261720-2018-04189
Device Sequence Number19193718
Product Code DZE
UDI-Device Identifier07898237568386
UDI-Public07898237568386
Combination Product (Y/N)N
Initial Reporter CountryES
PMA/510(K) Number
K101207
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 08/29/2018
Report Date (Section F) 08/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number109.586
Device Lot Number2823393
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/03/2018
Event Location Other
Date Report to Manufacturer08/03/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/03/2018
Initial Report FDA Received Date09/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age68 YR
-
-