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 DRIVE IMPLANT 5.0X13 MM; 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 DRIVE IMPLANT 5.0X13 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.998
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Tissue Damage (2104)
Date of Event 07/04/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.In telephone contact, the complainant informed that the information about lot number of the product was not available.
 
Event or Problem Description
(b)(4) ¿ the dentist reported that the dental implant had to be removed during its installation surgery.No further information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CM DRIVE IMPLANT 5.0X13 MM
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 Key8164640
Report Number3008261720-2018-05826
Device Sequence Number19339193
Product Code DZE
UDI-Device Identifier07899878023371
UDI-Public07899878023371
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K123022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 12/12/2018
Report Date (Section F) 11/20/2018
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 Health Professional
Device Catalogue Number109.998
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/14/2018
Event Location Other
Date Report to Manufacturer11/20/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/20/2018
Initial Report FDA Received Date12/14/2018
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 Age40 YR
-
-