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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 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM ZYGOMATIC IMPLANT 45.0 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.525
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Fistula (1862); Pain (1994); Tissue Damage (2104)
Date of Event 04/05/2018
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, it was informed that the dentist did not have information about lot number of the product.The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form and visual conference of the product returned by the dentist.
 
Event or Problem Description
(b)(4) ¿ the dentist reported that 5 months after the dental implant was installed in patient¿s mouth, its non-osseointegration was observed.Moreover, the patient presented bone type ii, bone graft was placed and fenestration has occurred.
 
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Brand Name
CM ZYGOMATIC IMPLANT 45.0 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 Key8511524
Report Number3008261720-2019-01537
Device Sequence Number941902
Product Code DZE
UDI-Device Identifier07898237567792
UDI-Public07898237567792
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K141777
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 04/12/2019
Report Date (Section F) 03/22/2019
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 Number109.525
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/12/2019
Event Location Other
Date Report to Manufacturer03/22/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/22/2019
Initial Report FDA Received Date04/12/2019
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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