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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JJGC S.A. TAPERED IMPLANT IF 5.0X10 SP; ENDOSSEOUS DENTAL IMPLANT
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JJGC S.A. TAPERED IMPLANT IF 5.0X10 SP; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number CD0902020
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/30/2024
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2024 in the patient's mouth.On (b)(6) 2024, non-osseointegration was verified.Patient presented with poor oral hygiene.No product was returned to the manufacturer.There were no reported patient injuries or complications.
 
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Brand Name
TAPERED IMPLANT IF 5.0X10 SP
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 Key19512279
Report Number0001222315-2024-001561
Device Sequence Number7515292
Product Code DZE
UDI-Device Identifier07899878038429
UDI-Public07899878038429
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2024
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 06/11/2024
Report Date (Section F) 05/16/2024
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 Date07/29/2026
Device Catalogue NumberCD0902020
Device Lot NumberGPM67
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/11/2024
Device Age32 MO
Event Location Other
Date Report to Manufacturer05/16/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/11/2024
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
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 SexMale
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