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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM ZYGOMATIC IMPLANT 50.0 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM ZYGOMATIC IMPLANT 50.0 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.527
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.
 
Event or Problem Description
(b)(4) ¿ the dentist reported that the dental implant has not osseointegrated, but he did not provided further information about the case.
 
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Brand Name
CM ZYGOMATIC IMPLANT 50.0 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 Key8351513
Report Number3008261720-2019-00689
Device Sequence Number2137629
Product Code DZE
UDI-Device Identifier07898237567815
UDI-Public07898237567815
Combination Product (Y/N)N
Initial Reporter CountryES
PMA/510(K) Number
K141777
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) 02/18/2019
Report Date (Section F) 01/29/2019
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 Date02/14/2021
Device Catalogue Number109.527
Device Lot Number83886
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/18/2019
Event Location Other
Date Report to Manufacturer01/29/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/29/2019
Initial Report FDA Received Date02/19/2019
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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