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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JJGC S.A. CM DRIVE IMPLANT, TITANIUM, 3.5X13 MM; ENDOSSEOUS DENTAL IMPLANT
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JJGC S.A. CM DRIVE IMPLANT, TITANIUM, 3.5X13 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 109.995
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Inflammation (1932); Fibrosis (3167)
Date of Event 06/24/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in ada 5.On (b)(6) 2020, loss of osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: mobility and inflammation.No further patient complications were reported.
 
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Brand Name
CM DRIVE IMPLANT, TITANIUM, 3.5X13 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 Key10764816
Report Number0001222315-2020-13143
Device Sequence Number1139190
Product Code DZE
UDI-Device Identifier07899878023340
UDI-Public07899878023340
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K123022
Number of Events Summarized1
Summary Report (Y/N)Y
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 10/30/2020
Report Date (Section F) 10/06/2020
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 Date04/26/2023
Device Model Number109.995
Device Catalogue Number109.995
Device Lot Number150130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/30/2020
Device Age26 MO
Event Location Other
Date Report to Manufacturer10/06/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/06/2020
Initial Report FDA Received Date10/30/2020
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 Age43 YR
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