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. CM TITAMAX EX IMPLANT 3.75X19; 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. CM TITAMAX EX IMPLANT 3.75X19; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109671
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 02/19/2015
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, 3 years and 4 months after the dental implant was installed in patient¿s mouth, its loss of osseointegration was observed.45 ncm of primary stability was achieved and the implant was immediately loaded.The patient presented bone type iii.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CM TITAMAX EX IMPLANT 3.75X19
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 Key7022281
Report Number3008261720-2017-04696
Device Sequence Number16440062
Product Code DZE
UDI-Device Identifier07898237569185
UDI-Public07898237569185
Combination Product (Y/N)N
Initial Reporter CountryBO
PMA/510(K) Number
K101945
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2015
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 06/21/2017
Report Date (Section F) 06/21/2017
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 Catalogue Number109671
Other Device ID Number07898237569185
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2017
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/10/2017
Event Location Other
Date Report to Manufacturer06/21/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/21/2017
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 Age89 YR
-
-