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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT JJGC S.A. TI DRIVE ACQUA IMPLANT (4.3) 4.3X8; ENDOSSEOUS DENTAL IMPLANT
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NEODENT JJGC S.A. TI DRIVE ACQUA IMPLANT (4.3) 4.3X8; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140757
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 09/14/2015
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.
 
Event or Problem Description
(b)(4).The dentist reported that 1 year after the dental implant was installed in intraoral region #14, it was verified its nonosseointegration.A 10 ncm of primary stability was achieved and immediate load was not performed.The patient presented insufficient bone quality/quantity (bone type iv).
 
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Brand Name
TI DRIVE ACQUA IMPLANT (4.3) 4.3X8
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 Key7012850
Report Number3008261720-2017-00528
Device Sequence Number13767079
Product Code DZE
UDI-Device Identifier07899878017127
UDI-Public07899878017127
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K133592
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2015
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/25/2015
Report Date (Section F) 09/25/2015
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 Catalogue Number140757
Other Device ID Number07899878017127
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2015
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/09/2017
Event Location Other
Date Report to Manufacturer09/25/2015
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/25/2015
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;
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