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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM ZYGOMATIC IMPLANT 45.0; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM ZYGOMATIC IMPLANT 45.0; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.525
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Unspecified Infection (1930); Tissue Damage (2104); Sinus Perforation (2277)
Date of Event 10/03/2017
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 20 days after dental implant was installed in mouth, its non-osseointegration was observed.A 35 ncm of primary stability was achieved and the implant was installed with immediately load.The patient presented bone type iv.".
 
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Brand Name
CM ZYGOMATIC IMPLANT 45.0
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 Key7251533
Report Number3008261720-2018-00626
Device Sequence Number111652
Product Code DZE
UDI-Device Identifier07898237567792
UDI-Public07898237567792
Combination Product (Y/N)N
Initial Reporter CountryES
PMA/510(K) Number
K141777
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/08/2018
Report Date (Section F) 01/18/2018
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 Dentist
Device Expiration Date04/21/2019
Device Catalogue Number109.525
Device Lot Number800182511
Other Device ID Number07898237567792
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/08/2018
Device Age42 MO
Event Location Other
Date Report to Manufacturer01/18/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/18/2018
Initial Report FDA Received Date02/08/2018
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;
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