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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) 3.5X8 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TI DRIVE ACQUA IMPLANT (3.3) 3.5X8 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140.752
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 11/08/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.After the evaluation was noticed that the lot number informed does not correspond to the item received.Therefore, the lot number was not considered.
 
Event or Problem Description
(b)(4) ¿ the dentist reported that almost 1 year and 2 months after the dental implant was installed in patient¿s mouth, its non- osseointegration was observed.
 
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Brand Name
TI DRIVE ACQUA IMPLANT (3.3) 3.5X8 MM
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 Key8249310
Report Number3008261720-2019-00272
Device Sequence Number13842335
Product Code DZE
UDI-Device Identifier07899878017073
UDI-Public07899878017073
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K133592
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/15/2019
Report Date (Section F) 01/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Catalogue Number140.752
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/15/2019
Event Location Other
Date Report to Manufacturer01/02/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/02/2019
Initial Report FDA Received Date01/15/2019
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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