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: JJGC S.A. CM DRIVE IMPLANT, TITANIUM, 4.3X8 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
 

JJGC S.A. CM DRIVE IMPLANT, TITANIUM, 4.3X8 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 109.1001
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Pain (1994)
Date of Event 01/09/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in ada 12.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: pain.No further patient complications were reported.
 
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in ada 12.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: pain.No further patient complications were reported.
 
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in ada 12.Details of surgery: immediate extraction site.On (b)(6) 2020, non-osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: pain.No further patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CM DRIVE IMPLANT, TITANIUM, 4.3X8 MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
JJGC S.A.
av. juscelino kubitschek de
oliveira, 3291 cic
curitiba PR 81270 -200
BR  81270-200
MDR Report Key10386301
Report Number0001222315-2020-08934
Device Sequence Number11667432
Product Code DZE
UDI-Device Identifier07899878023401
UDI-Public07899878023401
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K123022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Dentist
Type of Report Initial,Followup,Followup
Report Date (Section B) 06/04/2021
Report Date (Section F) 05/11/2021
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 Date11/29/2021
Device Model Number109.1001
Device Catalogue Number109.1001
Device Lot Number83894I
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/04/2021
Device Age38 MO
Event Location Other
Date Report to Manufacturer05/11/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/15/2020
Supplement Date Received by Manufacturer07/15/2020
05/11/2021
Initial Report FDA Received Date08/10/2020
Supplement Report FDA Received Date05/03/2021
06/04/2021
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;
-
-