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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JJGC S.A. TAPERED IMPLANT CF 3.5X16 NP; ENDOSSEOUS DENTAL IMPLANT
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JJGC S.A. TAPERED IMPLANT CF 3.5X16 NP; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number CD0903005
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/03/2022
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2022 in ada 21.On (b)(6) 2022, 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
TAPERED IMPLANT CF 3.5X16 NP
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 Key15132328
Report Number0001222315-2022-15853
Device Sequence Number6603468
Product Code DZE
UDI-Device Identifier07899878046028
UDI-Public07899878046028
Combination Product (Y/N)N
Initial Reporter StateNM
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2022
Device Explanted Year2022
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/29/2022
Report Date (Section F) 07/05/2022
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 NumberCD0903005
Device Catalogue NumberCD0903005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/29/2022
Event Location Other
Date Report to Manufacturer07/05/2022
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/29/2022
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexFemale
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