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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. FACILITY ACQUA IMPLANT 12; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. FACILITY ACQUA IMPLANT 12; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140738
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 09/19/2016
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, 4 months after the dental implant was installed in intraoral region #10, its non-osseointegration was observed.The implant was installed without immediately load and the patient presented insufficient bone quality/quantity (bone type ii).
 
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Brand Name
FACILITY ACQUA IMPLANT 12
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 Key7021423
Report Number3008261720-2017-04124
Device Sequence Number13776175
Product Code DZE
UDI-Device Identifier07899878017042
UDI-Public07899878017042
Combination Product (Y/N)N
Initial Reporter CountryES
PMA/510(K) Number
K150199
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) 01/19/2017
Report Date (Section F) 01/19/2017
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 Date10/24/2016
Device Catalogue Number140738
Device Lot Number800156647
Other Device ID Number07899878017042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2017
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/10/2017
Device Age23 MO
Event Location Other
Date Report to Manufacturer01/19/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/19/2017
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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