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, 5.0X18 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, 5.0X18 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 109.1008
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/18/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2018 in ada 20.On (b)(6) 2019, non-osseointegration was verified.Patient presented with poor oral hygiene.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CM DRIVE IMPLANT, TITANIUM, 5.0X18 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 Key10943449
Report Number0001222315-2020-15717
Device Sequence Number1220381
Product Code DZE
UDI-Device Identifier07899878023487
UDI-Public07899878023487
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K150182
Number of Events Summarized1
Summary Report (Y/N)Y
Device Implanted Year2018
Device Explanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 12/03/2020
Report Date (Section F) 11/09/2020
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 Date12/17/2021
Device Model Number109.1008
Device Catalogue Number109.1008
Device Lot Number86893I
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/03/2020
Device Age36 MO
Event Location Other
Date Report to Manufacturer11/09/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/09/2020
Initial Report FDA Received Date12/04/2020
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 Age49 YR
-
-