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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JJGC S.A. CM DRIVE IMPLANT, TITANIUM, 5.0X11.5 MM; ENDOSSEOUS DENTAL IMPLANT
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JJGC S.A. CM DRIVE IMPLANT, TITANIUM, 5.0X11.5 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 109.1003
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Fibrosis (3167)
Date of Event 10/02/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2017 in ada 19.On (b)(6) 2020, loss of osseointegration was verified.Patient presented with bruxism.No product was returned to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.
 
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Brand Name
CM DRIVE IMPLANT, TITANIUM, 5.0X11.5 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 Key11650002
Report Number0001222315-2021-05937
Device Sequence Number14367049
Product Code DZE
UDI-Device Identifier07899878023425
UDI-Public07899878023425
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K123022
Summary Report (Y/N)Y
Device Implanted Year2017
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) 04/12/2021
Report Date (Section F) 03/17/2021
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 Date10/26/2022
Device Model Number109.1003
Device Catalogue Number109.1003
Device Lot Number800325246I
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/12/2021
Device Age36 MO
Event Location Other
Date Report to Manufacturer03/17/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/17/2021
Initial Report FDA Received Date04/12/2021
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;
Patient Age75 YR
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