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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JJGC S.A. GM DRIVE ACQUA IMPLANT,TI,5.0X16; ENDOSSEOUS DENTAL IMPLANT
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JJGC S.A. GM DRIVE ACQUA IMPLANT,TI,5.0X16; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140.974
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/21/2024
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2024 in ada 20.On (b)(6) 2024, loss of osseointegration was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.
 
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Brand Name
GM DRIVE ACQUA IMPLANT,TI,5.0X16
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 Key20052421
Report Number0001222315-2024-002240
Device Sequence Number7971110
Product Code DZE
UDI-Device Identifier07899878025191
UDI-Public07899878025191
Combination Product (Y/N)N
Initial Reporter StateIL
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) 08/23/2024
Report Date (Section F) 07/30/2024
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 Date06/29/2026
Device Catalogue Number140.974
Device Lot NumberMAX07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/23/2024
Device Age36 MO
Event Location Other
Date Report to Manufacturer07/30/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/23/2024
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 SexMale
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