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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM DRIVE IMPLANT, TITANIUM, 5.0X13 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM DRIVE IMPLANT, TITANIUM, 5.0X13 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.998
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 09/26/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reported that almost 3 months after the dental implant was placed in the patient's mouth, the implant did not achieve osseointegration in type ii bone.The clinician reported this patient with poor oral hygiene has a bone defect.The product will be forwarded to the manufacturer for investigation.There were no reported patient complications.
 
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Brand Name
CM DRIVE IMPLANT, TITANIUM, 5.0X13 MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NEODENT - JJGC S.A.
av. juscelino kubitschek de
oliveira, 3291 cic
curitiba, 81270 -200
BR  81270-200
MDR Report Key9250617
Report Number1222315-2019-11413
Device Sequence Number2003065
Product Code DZE
UDI-Device Identifier07899878023371
UDI-Public7899878023371
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 10/29/2019
Report Date (Section F) 10/16/2019
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 Date02/23/2023
Device Catalogue Number109.998
Device Lot Number132714I
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/15/2019
Device Age17 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer10/16/2019
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
FULL UPPER DENTURE PLACEMENT
Outcome Attributed to Adverse Event Required Intervention;
Patient Age72 YR
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