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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX EX IMPL TI 3.75X17; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM TITAMAX EX IMPL TI 3.75X17; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.670
Medical Device Problem Codes Failure to Osseointegrate (1863); Loss of Osseointegration (2408)
Health Effect - Clinical Codes Unspecified Infection (1930); Pain (1994); Tissue Damage (2104)
Date of Event 07/10/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
 
Event or Problem Description
The clinician reports 9 months after the dental implant and denture were placed in ada site 4 in the mouth, the implant had not achieved integration in type iii bone.Clinician reports an infection and dehiscence.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.
 
Additional Manufacturer Narrative
Exemption number: e2015015.(b)(4).After the evaluation, the event was considered as loss of osseointegration.
 
Event or Problem Description
The clinician reports 9 months after the dental implant and denture were placed in ada site 4 in the mouth, the implant had not achieved integration in type iii bone.Clinician reports an infection and dehiscence.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.(b)(4).
 
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Brand Name
CM TITAMAX EX IMPL TI 3.75X17
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 Key7830363
Report Number3008261720-2018-03939
Device Sequence Number1808556
Product Code DZE
UDI-Device Identifier07898237569178
UDI-Public07898237569178
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K101945
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date (Section B) 08/29/2018
Report Date (Section F) 07/18/2018
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 Expiration Date06/13/2019
Device Catalogue Number109.670
Device Lot Number800137696
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/08/2018
Device Age3 MO
Event Location Other
Date Report to Manufacturer07/18/2018
Initial Date Received by Manufacturer 07/18/2018
Supplement Date Received by Manufacturer10/22/2018
Initial Report FDA Received Date08/29/2018
Supplement Report FDA Received Date11/08/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
DENTURE PLACEMENT; DENTURE PLACEMENT
Outcome Attributed to Adverse Event Required Intervention;
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