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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. FACILITY IMPLANT 14.0 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. FACILITY IMPLANT 14.0 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.739
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 05/21/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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.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, 2 months after the dental implant was installed in patient¿s mouth, its non-osseointegration was observed.
 
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Brand Name
FACILITY IMPLANT 14.0 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 Key8823713
Report Number3008261720-2019-03779
Device Sequence Number16900918
Product Code DZE
UDI-Device Identifier07898237569529
UDI-Public07898237569529
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K123022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/24/2019
Report Date (Section F) 07/02/2019
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 Number109.739
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/24/2019
Event Location Other
Date Report to Manufacturer07/02/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/02/2019
Initial Report FDA Received Date07/24/2019
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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