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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM DRIVE ACQUA IMPLANT 4.3X18; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM DRIVE ACQUA IMPLANT 4.3X18; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140.897
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 04/05/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
 
Event or Problem Description
(b)(4) - the dentist reported that 2 months after dental implant was installed in patient¿s mouth, its non-osseointegration was observed.No further information was provided.
 
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Brand Name
CM DRIVE ACQUA IMPLANT 4.3X18
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NEODENT - JJGC S.A.
av. juscelino kubitschek de
oliveira, 3291 cic
curitiba PR 81270 -200
BR  81270-200
MDR Report Key7629478
Report Number3008261720-2018-02715
Device Sequence Number16764695
Product Code DZE
UDI-Device Identifier07899878018070
UDI-Public07899878018070
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K150182
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 06/22/2018
Report Date (Section F) 05/29/2018
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 Dentist
Device Expiration Date05/25/2017
Device Catalogue Number140.897
Device Lot Number800193923I
Other Device ID Number07899878018070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/22/2018
Device Age35 MO
Event Location Other
Date Report to Manufacturer05/29/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/29/2018
Initial Report FDA Received Date06/22/2018
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;
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