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. TITAMAX IMPLANT WITH MOUNT 3.3X13; 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. TITAMAX IMPLANT WITH MOUNT 3.3X13; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109142
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 04/24/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
 
Event or Problem Description
(b)(4) - the dentist reported that, 7 years after the dental implant was installed in intraoral region #7, its loss of osseointegration was observed.A 45 ncm of primary stability was achieved and the patient presented bone type iv.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TITAMAX IMPLANT WITH MOUNT 3.3X13
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 Key7021975
Report Number3008261720-2017-04530
Device Sequence Number1496793
Product Code DZE
UDI-Device Identifier07898237566672
UDI-Public07898237566672
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K101207
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2017
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 06/06/2017
Report Date (Section F) 06/06/2017
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 Dentist
Device Expiration Date05/06/2015
Device Catalogue Number109142
Device Lot Number800005300
Other Device ID Number07898237566672
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/10/2017
Device Age83 MO
Event Location Other
Date Report to Manufacturer06/06/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/06/2017
Initial Report FDA Received Date11/10/2017
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 Age51 YR
-
-