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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JJGC S.A. CM TITAMAX EX IMPL TI 3.75X15; ENDOSSEOUS DENTAL IMPLANT
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JJGC S.A. CM TITAMAX EX IMPL TI 3.75X15; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 109.669
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/08/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2021 in ada 4.On (b)(6) 2021, non-osseointegration was verified.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 3.75X15
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 Key11517712
Report Number0001222315-2021-04484
Device Sequence Number3829353
Product Code DZE
UDI-Device Identifier07898237569161
UDI-Public07898237569161
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K101945
Summary Report (Y/N)Y
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 03/18/2021
Report Date (Section F) 02/22/2021
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 Date06/22/2021
Device Model Number109.669
Device Catalogue Number109.669
Device Lot Number800091570
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/18/2021
Device Age56 MO
Event Location Other
Date Report to Manufacturer02/22/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/22/2021
Initial Report FDA Received Date03/18/2021
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;
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