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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. TITAMAX SMART IMPLANT (4.1) 4.0X13; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TITAMAX SMART IMPLANT (4.1) 4.0X13; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.163
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Tissue Damage (2104)
Date of Event 10/26/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
 
Event or Problem Description
Rp 011820 - the dentist reported that nearly 1 month after dental implant was installed in patient¿s mouth, it had to be removed because the patient was in pain.No further information was provided.
 
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Brand Name
TITAMAX SMART 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 Key7508967
Report Number3008261720-2018-02213
Device Sequence Number1225126
Product Code DZE
UDI-Device Identifier07898237566771
UDI-Public07898237566771
Combination Product (Y/N)N
Initial Reporter CountryES
PMA/510(K) Number
K133510
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 05/11/2018
Report Date (Section F) 04/25/2018
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 Dentist
Device Expiration Date03/01/2014
Device Catalogue Number109.163
Device Lot Number800118324
Other Device ID Number07898237566771
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/11/2018
Device Age43 MO
Event Location Other
Date Report to Manufacturer04/25/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/25/2018
Initial Report FDA Received Date05/11/2018
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;
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