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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 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TI TITAMAX EX ACQUA IMPLANT (4.1) 4.0X13 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140.590
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Unspecified Infection (1930); Tissue Damage (2104)
Date of Event 09/28/2018
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 on the guarantee form does not correspond to the item informed on the guarantee form.Therefore, the lot number was not considered.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 7 months after the dental implant was installed in patient¿s mouth, its non-osseointegration was observed.In addition, the patient presented bone type ii.
 
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Brand Name
TI TITAMAX EX ACQUA IMPLANT (4.1) 4.0X13 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 Key8119265
Report Number3008261720-2018-05691
Device Sequence Number18889349
Product Code DZE
UDI-Device Identifier07899878016427
UDI-Public07899878016427
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 Year2018
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 11/30/2018
Report Date (Section F) 11/12/2018
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 Number140.590
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/30/2018
Event Location Other
Date Report to Manufacturer11/12/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/12/2018
Initial Report FDA Received Date11/30/2018
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 Age45 YR
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