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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. TITAMAX IMPLANT WITH MOUNT 3.3X9; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TITAMAX IMPLANT WITH MOUNT 3.3X9; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109140
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Unspecified Infection (1930); Tissue Damage (2104)
Date of Event 01/01/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.
 
Event or Problem Description
(b)(4) - the dentist reported that 1 year after the dental implant was installed in patient's mouth, it was verified its non-osseointegration.Twenty ncm of primary stability was achieved and immediate load was not performed.
 
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Brand Name
TITAMAX IMPLANT WITH MOUNT 3.3X9
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 Key7017360
Report Number3008261720-2017-01636
Device Sequence Number11150082
Product Code DZE
UDI-Device Identifier07898237566658
UDI-Public07898237566658
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K101207
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 05/05/2016
Report Date (Section F) 05/05/2016
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 Date02/01/2018
Device Catalogue Number109140
Device Lot Number800074911
Other Device ID Number07898237566658
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2016
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/10/2017
Event Location Other
Date Report to Manufacturer05/05/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/05/2016
Initial Report FDA Received Date11/10/2017
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 Age46 YR
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