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 Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 01/01/2016
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, after the dental implant was installed in patient¿s mouth, at the time of uncovering to perform the patient¿s prosthetic rehabilitation, it was seen that the dental implant had not osseointegrated.Thirty-five ncm of primary stability was achieved.
 
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 Key7020510
Report Number3008261720-2017-03392
Device Sequence Number13692118
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
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/23/2017
Report Date (Section F) 01/23/2017
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 Number109142
Other Device ID Number07898237566672
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2017
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/10/2017
Event Location Other
Date Report to Manufacturer01/23/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/23/2017
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;
-
-