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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. TI TITAMAX EX ACQUA IMPLANT (4.1)4.0X13; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TI TITAMAX EX ACQUA IMPLANT (4.1)4.0X13; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140590
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 02/06/2015
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.
 
Event or Problem Description
(b)(4).The dentist reported that 2 months after the dental implant was installed in intraoral region #23, it was verified its nonosseointegration.Patient presented bone type ii and implant was immediately carried out.
 
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Brand Name
TI TITAMAX EX ACQUA IMPLANT (4.1)4.0X13
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 Key7024125
Report Number3008261720-2017-00561
Device Sequence Number16375537
Product Code DZE
UDI-Device Identifier07899878016427
UDI-Public07899878016427
Combination Product (Y/N)N
Initial Reporter CountryMX
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) 09/29/2015
Report Date (Section F) 09/29/2015
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 Number140590
Other Device ID Number07899878016427
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/13/2017
Event Location Other
Date Report to Manufacturer09/29/2015
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/29/2015
Initial Report FDA Received Date11/13/2017
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 Age60 YR
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