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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) 4.0X11 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TI TITAMAX EX ACQUA IMPLANT (4.1) 4.0X11 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140589
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Unspecified Infection (1930); Tissue Damage (2104)
Date of Event 03/08/2019
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 item received is different from the item reported on guarantee form by the complainant.Therefore, the lot number was not considered.The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form and visual conference of the product returned by the dentist.
 
Event or Problem Description
(b)(4) ¿ the dentist reported that 1 year and 10 months after the dental implant was installed in patient¿s mouth, its non- osseointegration was observed.
 
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Brand Name
TI TITAMAX EX ACQUA IMPLANT (4.1) 4.0X11 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 Key8490902
Report Number3008261720-2019-01445
Device Sequence Number19263339
Product Code DZE
UDI-Device Identifier07899878016410
UDI-Public07899878016410
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 Year2019
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 04/08/2019
Report Date (Section F) 03/14/2019
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 Health Professional
Device Catalogue Number140589
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/08/2019
Event Location Other
Date Report to Manufacturer03/14/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/14/2019
Initial Report FDA Received Date04/08/2019
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;
Patient Age36 YR
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