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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JJGC S.A. CM TITAMAX EX IMPL TI 4.0X15; ENDOSSEOUS DENTAL IMPLANT
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JJGC S.A. CM TITAMAX EX IMPL TI 4.0X15; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 109.639
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/10/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2017 in ada 8.On (b)(6) 2021, the implant was removed upon clinician¿s decision.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
 
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Brand Name
CM TITAMAX EX IMPL TI 4.0X15
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
JJGC S.A.
av. juscelino kubitschek de
oliveira, 3291 cic
curitiba PR 81270 -200
BR  81270-200
MDR Report Key11672752
Report Number0001222315-2021-06231
Device Sequence Number14215386
Product Code DZE
UDI-Device Identifier07898237568874
UDI-Public07898237568874
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 04/15/2021
Report Date (Section F) 03/22/2021
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 Date07/30/2021
Device Model Number109.639
Device Catalogue Number109.639
Device Lot Number64456
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/15/2021
Device Age56 MO
Event Location Other
Date Report to Manufacturer03/22/2021
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/15/2021
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;
Patient Age60 YR
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