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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) 3.5X16; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TI DRIVE ACQUA IMPLANT (3.3) 3.5X16; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140756
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 12/18/2015
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.
 
Event or Problem Description
(b)(4).The dentist reported that 1.5 months after the dental implant was installed in intraoral region #7 it was verified its non- osseointegration.30 n.Cm.Of primary stability was achieved and immediate load was not performed.The patient presented bone type iii.
 
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Brand Name
TI DRIVE ACQUA IMPLANT (3.3) 3.5X16
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 Key7015902
Report Number3008261720-2017-01174
Device Sequence Number13808875
Product Code DZE
UDI-Device Identifier07899878017110
UDI-Public07899878017110
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K133592
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2015
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/18/2016
Report Date (Section F) 01/18/2016
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 Date06/05/2017
Device Catalogue Number140756
Device Lot Number800196607
Other Device ID Number07899878017110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2016
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/09/2017
Device Age6 MO
Event Location Other
Date Report to Manufacturer01/18/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/18/2016
Initial Report FDA Received Date11/09/2017
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;
Patient Age44 YR
Patient Weight68
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