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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM DRIVE ACQUA IMPL TI 5.0X16; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM DRIVE ACQUA IMPL TI 5.0X16; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number N/A
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 08/19/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reported that over 14 months after the dental implant was placed in ada site 4 in the patient's mouth, the implant lost osseointegration.The product will be forwarded to the manufacturer for investigation.There were no reported patient complications.
 
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Brand Name
CM DRIVE ACQUA IMPL TI 5.0X16
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 Key9245007
Report Number1222315-2019-11272
Device Sequence Number11413084
Product Code DZE
UDI-Device Identifier07899878016885
UDI-Public7899878016885
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 10/28/2019
Report Date (Section F) 10/14/2019
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 Date07/18/2019
Device Model NumberN/A
Device Catalogue Number140.687
Device Lot Number800310045I
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/14/2019
Device Age11 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer10/14/2019
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/28/2019
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 Age60 YR
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