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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX EX IMPLANT 3.5X15 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM TITAMAX EX IMPLANT 3.5X15 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.664
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 01/01/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.In telephone contact, the complainant informed that the information about lot number of the product was not available.
 
Event or Problem Description
(b)(4).The dentist reported that after the dental implant was installed in patient¿s mouth, its non-osseointegration was observed.Moreover, 45ncm of primary stability was achieved and immediate load procedure was performed.
 
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Brand Name
CM TITAMAX EX IMPLANT 3.5X15 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 Key8228587
Report Number3008261720-2019-00170
Device Sequence Number19332121
Product Code DZE
UDI-Device Identifier07898237569116
UDI-Public07898237569116
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K101945
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) 01/08/2019
Report Date (Section F) 12/17/2018
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 Catalogue Number109.664
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/08/2019
Event Location Other
Date Report to Manufacturer12/17/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/17/2018
Initial Report FDA Received Date01/08/2019
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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