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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT JJGC S.A. TI TITAMAX EX ACQUA IMPLANT (4.1) 4.0X13; ENDOSSEOUS DENTAL IMPLANT
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NEODENT JJGC S.A. TI TITAMAX EX ACQUA IMPLANT (4.1) 4.0X13; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140590
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Unspecified Infection (1930); Tissue Damage (2104)
Date of Event 04/03/2017
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, 3 months after the dental implant was installed in intraoral region #4, its non-osseointegration was observed.10 ncm of primary stability was achieved and the implant was installed without immediately load.The patient presented bone type iv.
 
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Brand Name
TI TITAMAX EX ACQUA IMPLANT (4.1) 4.0X13
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 Key7021602
Report Number3008261720-2017-04279
Device Sequence Number19084050
Product Code DZE
UDI-Device Identifier07899878016427
UDI-Public07899878016427
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K133592
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 04/25/2017
Report Date (Section F) 04/25/2017
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 Date09/24/2017
Device Catalogue Number140590
Device Lot Number15847
Other Device ID Number07899878016427
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2017
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/10/2017
Device Age19 MO
Event Location Other
Date Report to Manufacturer04/25/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/25/2017
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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