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 IMPLANT (5.0)4.5X11; 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 IMPLANT (5.0)4.5X11; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109328
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Pain (1994); Swelling (2091); Tissue Damage (2104)
Date of Event 02/04/2016
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, 10 days after the dental implant was installed in patient¿s mouth, its non-osseointegration was observed.Forty ncm of primary stability was achieved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TI TITAMAX IMPLANT (5.0)4.5X11
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 Key7030961
Report Number3008261720-2017-05808
Device Sequence Number1013416
Product Code DZE
UDI-Device Identifier07898237567136
UDI-Public07898237567136
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K101207
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2016
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/21/2017
Report Date (Section F) 09/21/2017
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 Number109328
Other Device ID Number07898237567136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2017
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/14/2017
Event Location Other
Date Report to Manufacturer09/21/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/21/2017
Initial Report FDA Received Date11/14/2017
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 Age49 YR
-
-