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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM DRIVE ACQUA IMPLANT, TITANIUM, 4.3X18; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM DRIVE ACQUA IMPLANT, TITANIUM, 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 02/08/2018
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
The clinician reported 4.5 months after the dental implant and abutment were placed in ada site 2, the implant lost osseointegration in type iii bone.Clinician reports non-compliance with diet.The product will be forwarded to the manufacturer for investigation.There were no reported complications.
 
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.The dentist reported that immediate load and immediate implant were performed.
 
Event or Problem Description
The clinician reported 4.5 months after the dental implant and abutment were placed in ada site 2, the implant lost osseointegration in type iii bone.Clinician reports non-compliance with diet.The product will be forwarded to the manufacturer for investigation.There were no reported complications.(b)(4).
 
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Brand Name
CM DRIVE ACQUA IMPLANT, TITANIUM, 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 Key7336064
Report Number3008261720-2018-01179
Device Sequence Number79245
Product Code DZE
UDI-Device Identifier07899878018070
UDI-Public07899878018070
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K150182
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Dental Assistant
Type of Report Initial,Followup
Report Date (Section B) 03/13/2018
Report Date (Section F) 02/16/2018
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 Date06/07/2019
Device Catalogue Number140.897
Device Lot Number800304026I
Other Device ID Number07899878018070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/22/2018
Device Age1 MO
Event Location Other
Date Report to Manufacturer02/16/2018
Initial Date Received by Manufacturer 02/16/2018
Supplement Date Received by Manufacturer06/05/2018
Initial Report FDA Received Date03/13/2018
Supplement 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
Concomitant Medical Products
and Therapy/Usage Dates
ABUTMENT REMOVAL; ABUTMENT REMOVAL; ABUTMENT REMOVAL
Outcome Attributed to Adverse Event Required Intervention;
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