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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. TITAMAX IMPLANT WITH MOUNT 3.3X13 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TITAMAX IMPLANT WITH MOUNT 3.3X13 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.142
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 12/12/2012
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
In telephone contact, it was informed that the dentist did not have information about lot number of the product.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 4 months after the dental implant was installed in patient¿s mouth, its non-osseointegration was observed.
 
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Brand Name
TITAMAX IMPLANT WITH MOUNT 3.3X13 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 Key9248978
Report Number3008261720-2019-05501
Device Sequence Number2031138
Product Code DZE
UDI-Device Identifier07898237566672
UDI-Public07898237566672
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K101207
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2012
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 10/29/2019
Report Date (Section F) 09/30/2019
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 Number109.142
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/29/2019
Event Location Other
Date Report to Manufacturer09/30/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2019
Initial Report FDA Received Date10/29/2019
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;
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