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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. FACILITY IMPLANT 14.0 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. FACILITY IMPLANT 14.0 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.739
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 12/14/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.The dentist has exceeded the recommended installation torque (60 ncm).The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form, visual conference of the product returned by the dentist and the evaluation of relevant production records.
 
Event or Problem Description
(b)(4).The dentist reported that almost 2 months after the dental implant was installed in intraoral region 32#, its non-osseointegration was observed.Moreover, 50n.Cm of primary stability was achieved, the patient presented bone type ii, immediate implant was performed and immediate load procedure was done.
 
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Brand Name
FACILITY IMPLANT 14.0 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 Key8697801
Report Number3008261720-2019-02707
Device Sequence Number2446067
Product Code DZE
UDI-Device Identifier07898237569529
UDI-Public07898237569529
Combination Product (Y/N)N
Initial Reporter CountryES
PMA/510(K) Number
K123022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 06/13/2019
Report Date (Section F) 05/24/2019
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 Expiration Date04/03/2019
Device Catalogue Number109.739
Device Lot Number800124480
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/13/2019
Device Age56 MO
Event Location Other
Date Report to Manufacturer05/24/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/24/2019
Initial Report FDA Received Date06/13/2019
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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