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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. TITAMAX SMART EX IMPLANT (4.1)4.0X9; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TITAMAX SMART EX IMPLANT (4.1)4.0X9; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109780
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 06/30/2015
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.
 
Event or Problem Description
(b)(4) - the dentist reported that 1.5 months after two dental implants were installed in intraoral regions #19 and #20, it was verified their non-osseointegration.A 45 ncm of primary stability was achieved and immediate load was not performed.Patient presented insufficient bone quality/quantity (bone type iii) and bone graft was executed.
 
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Brand Name
TITAMAX SMART EX IMPLANT (4.1)4.0X9
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 Key7013054
Report Number3008261720-2017-00713
Device Sequence Number11198771
Product Code DZE
UDI-Device Identifier07898237569888
UDI-Public07898237569888
Combination Product (Y/N)N
Initial Reporter CountryES
PMA/510(K) Number
K133510
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2015
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 10/13/2015
Report Date (Section F) 10/13/2015
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 Date05/02/2019
Device Catalogue Number109780
Device Lot Number800129995
Other Device ID Number07898237569888
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2015
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/09/2017
Device Age13 MO
Event Location Other
Date Report to Manufacturer10/13/2015
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/13/2015
Initial Report FDA Received Date11/09/2017
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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