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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX EX IMPLANT 3.75X15 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM TITAMAX EX IMPLANT 3.75X15 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.669
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 03/06/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form, visual conference of the product returned by the dentist and the evaluation of relevant production records.
 
Event or Problem Description
(b)(4).The dentist reported that almost 3 months after the dental implant was installed in patient¿s mouth, its non-osseointegration was observed.
 
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Brand Name
CM TITAMAX EX IMPLANT 3.75X15 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 Key8490865
Report Number3008261720-2019-01422
Device Sequence Number1962560
Product Code DZE
UDI-Device Identifier07898237569161
UDI-Public07898237569161
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K101945
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 04/08/2019
Report Date (Section F) 03/14/2019
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 Expiration Date05/29/2022
Device Catalogue Number109.669
Device Lot Number800304812
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/08/2019
Device Age22 MO
Event Location Other
Date Report to Manufacturer03/14/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/14/2019
Initial Report FDA Received Date04/08/2019
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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