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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 01/26/2017
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 the dental implant was removed during its installation surgery.There is no information about implant replacement in the same surgery.The implant was being installed in intraoral region #19.
 
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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 Key7035175
Report Number3008261720-2017-06080
Device Sequence Number19341968
Product Code DZE
UDI-Device Identifier07899878018070
UDI-Public07899878018070
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K150182
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 11/15/2017
Report Date (Section F) 10/05/2017
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 Date04/14/2017
Device Catalogue Number140.897
Device Lot Number800186664I
Other Device ID Number07899878018070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2017
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/15/2017
Device Age21 MO
Event Location Other
Date Report to Manufacturer10/05/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/05/2017
Initial Report FDA Received Date11/15/2017
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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