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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 Codes Pain (1994); Swelling (2091); Tissue Damage (2104)
Date of Event 11/20/2015
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 1 month after the dental implant was installed in patient¿s mouth, its non-osseointegration was observed.In addition, the patient presented bone type ii.
 
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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 Key8011213
Report Number3008261720-2018-05209
Device Sequence Number1262910
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 Year2015
Device Explanted Year2015
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 10/26/2018
Report Date (Section F) 10/05/2018
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 Number109.739
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/26/2018
Event Location Other
Date Report to Manufacturer10/05/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/05/2018
Initial Report FDA Received Date10/28/2018
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;
Patient Age52 YR
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