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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM DRIVE IMPLANT 5.0X18; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM DRIVE IMPLANT 5.0X18; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.898
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 12/12/2016
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 was removed during its installation surgery.There is no information about implant replacement in the same surgery.
 
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Brand Name
CM DRIVE IMPLANT 5.0X18
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 Key7035330
Report Number3008261720-2017-06079
Device Sequence Number11298696
Product Code DZE
UDI-Device Identifier07899878001065
UDI-Public07899878001065
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K150182
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) 11/15/2017
Report Date (Section F) 10/05/2017
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 Date09/03/2020
Device Catalogue Number109.898
Device Lot Number800208080I
Other Device ID Number07899878001065
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2017
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/15/2017
Device Age15 MO
Event Location Other
Date Report to Manufacturer10/05/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/05/2017
Initial Report FDA Received Date11/15/2017
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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