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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 140.589
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Unspecified Infection (1930); Tissue Damage (2104)
Date of Event 02/18/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form, visual conference of the product returned by the dentist and the evaluation of relevant production records.Moreover, considering the surgical methodology, it was seen that the dentist has selected an implant design which is not recommended for the patient's bone quality.
 
Event or Problem Description
(b)(4) ¿ the dentist reported that 1 year and 23 days after the dental implant was installed in patient¿s mouth, its non- osseointegration was observed.Moreover, the patient presented bone type ii.
 
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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 Key8446033
Report Number3008261720-2019-01255
Device Sequence Number16865679
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 Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 03/22/2019
Report Date (Section F) 02/27/2019
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 Expiration Date11/28/2019
Device Catalogue Number140.589
Device Lot Number800329194
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/22/2019
Device Age15 MO
Event Location Other
Date Report to Manufacturer02/27/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/27/2019
Initial Report FDA Received Date03/22/2019
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 Age48 YR
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