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 DRIVE ACQUA IMPLANT (4.3) 4.3X8; 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 DRIVE ACQUA IMPLANT (4.3) 4.3X8; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140757
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 02/23/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.
 
Event or Problem Description
(b)(4) - the dentist reported that almost 5 months after the dental implant was installed in intraoral region #14, it was verified its non- osseointegration.Ten ncm of primary stability was achieved and immediate load was not performed.The patient presented insufficient bone quality/ quantity (bone type iii) and bone graft was executed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TI DRIVE ACQUA IMPLANT (4.3) 4.3X8
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 Key7016985
Report Number3008261720-2017-01317
Device Sequence Number1549249
Product Code DZE
UDI-Device Identifier07899878017127
UDI-Public07899878017127
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K133592
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2016
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/29/2016
Report Date (Section F) 02/29/2016
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 Date06/26/2017
Device Catalogue Number140757
Device Lot Number800199811I
Other Device ID Number07899878017127
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/29/2016
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/10/2017
Device Age8 MO
Event Location Other
Date Report to Manufacturer02/29/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/29/2016
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;
-
-