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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 109523
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 02/13/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.
 
Event or Problem Description
(b)(4) - the dentist reported that 1 month after two dental implants were installed in intraoral regions #4 and #13 it was verified its non- osseointegration.Forty ncm of primary stability was achieved and immediate load was performed.The patient presented bone type i.
 
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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 Key7017380
Report Number3008261720-2017-01658
Device Sequence Number10792735
Product Code DZE
UDI-Device Identifier07898237567778
UDI-Public07898237567778
Combination Product (Y/N)N
PMA/510(K) Number
K141777
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2016
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 04/14/2016
Report Date (Section F) 04/14/2016
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 Date10/23/2016
Device Catalogue Number109523
Device Lot Number800068912
Other Device ID Number07898237567778
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2016
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/10/2017
Device Age40 MO
Event Location Other
Date Report to Manufacturer04/14/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/14/2016
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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