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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. TI DRIVE ACQUA IMPLANT (3.3) 3.5X11.5; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TI DRIVE ACQUA IMPLANT (3.3) 3.5X11.5; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140.754
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 01/01/2016
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 having to remove the dental implant after its osseointegration, because the abutment was substituted and the new abutment got stuck into the implant.As it was not possible to remove only the abutment, the implant was also removed.
 
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Brand Name
TI DRIVE ACQUA IMPLANT (3.3) 3.5X11.5
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 Key7018904
Report Number3008261720-2017-02337
Device Sequence Number16395371
Product Code DZE
UDI-Device Identifier07899878017097
UDI-Public07899878017097
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K133592
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/14/2016
Report Date (Section F) 07/14/2016
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 Date07/24/2017
Device Catalogue Number140.754
Device Lot Number800203762I
Other Device ID Number07899878017097
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2016
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/10/2017
Event Location Other
Date Report to Manufacturer07/14/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/14/2016
Initial Report FDA Received Date11/10/2017
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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