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 ACQUA IMPLANT 4.3X18 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 ACQUA IMPLANT 4.3X18 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140.897
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 05/08/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
 
Event or Problem Description
(b)(4).The dentist reported that he had to remove the dental implant on the same day of installation surgery.No further information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CM DRIVE ACQUA IMPLANT 4.3X18 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 Key7868741
Report Number3008261720-2018-04540
Device Sequence Number1964281
Product Code DZE
UDI-Device Identifier07899878018070
UDI-Public07899878018070
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K150182
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) 09/12/2018
Report Date (Section F) 08/27/2018
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 Expiration Date06/12/2017
Device Catalogue Number140.897
Device Lot Number800197712I
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/12/2018
Device Age35 MO
Event Location Other
Date Report to Manufacturer08/27/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/27/2018
Initial Report FDA Received Date09/12/2018
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;
-
-