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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX EX ACQUA IMPLANT 4.0X13 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM TITAMAX EX ACQUA IMPLANT 4.0X13 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 140.638
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 12/12/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
In telephone contact, it was informed that the dentist did not have information about lot number of the product.Considering the surgical methodology, it was seen that the dentist has selected an implant design which is not recommended for the patient's bone quality.The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form and visual conference of the product returned by the dentist.
 
Event or Problem Description
(b)(4).The dentist reported that 1 month after the dental implant was installed in patient¿s mouth, its non-osseointegration was observed.Moreover, 30n.Cm of primary stability was achieved, the patient presented bone type ii and immediate implant was performed.
 
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Brand Name
CM TITAMAX EX ACQUA IMPLANT 4.0X13 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 Key9716962
Report Number3008261720-2020-00799
Device Sequence Number355115
Product Code DZE
UDI-Device Identifier07899878016571
UDI-Public07899878016571
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K133592
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/17/2020
Report Date (Section F) 01/21/2020
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 Model Number140.638
Device Catalogue Number140.638
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/17/2020
Event Location Other
Date Report to Manufacturer01/21/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/21/2020
Initial Report FDA Received Date02/17/2020
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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