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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM ZYGOMATIC IMPLANT 35.0; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM ZYGOMATIC IMPLANT 35.0; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.523
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 11/18/2015
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
 
Event or Problem Description
(b)(4) - the dentist reported that almost 2 weeks after the dental implant was installed in intraoral region #5, it was verified its non- osseointegration.Thirty-five ncm of primary stability was achieved and immediate load was not performed.The patient presented insufficient bone quality/ quantity (bone type iv).
 
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Brand Name
CM ZYGOMATIC IMPLANT 35.0
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 Key7018857
Report Number3008261720-2017-02312
Device Sequence Number13482386
Product Code DZE
UDI-Device Identifier07898237567778
UDI-Public07898237567778
Combination Product (Y/N)N
Initial Reporter CountryES
PMA/510(K) Number
K141777
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) 06/14/2016
Report Date (Section F) 06/14/2016
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 Date05/11/2016
Device Catalogue Number109.523
Device Lot Number800001430
Other Device ID Number07898237567778
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2016
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/10/2017
Event Location Other
Date Report to Manufacturer06/14/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/14/2016
Initial Report FDA Received Date11/10/2017
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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