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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JJGC S.A. SELF-DRILLING ANCHORAGE IMPL MB TI 1.6X7; ENDOSSEOUS DENTAL IMPLANT
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JJGC S.A. SELF-DRILLING ANCHORAGE IMPL MB TI 1.6X7; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.496
Device Problem Failure to Osseointegrate (1863)
Patient Problems Hemorrhage/Bleeding (1888); Fibrosis (3167)
Event Date 11/06/2023
Event Type  Injury  
Event Description
The clinician reports the implant was inserted (b)(6) 2023 in ada 2.Details of surgery: implant surface not completely covered with bone.On 2023-11-06, non-osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: mobility and bleeding.No further patient complications were reported.
 
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Brand Name
SELF-DRILLING ANCHORAGE IMPL MB TI 1.6X7
Type of Device
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 Key18294270
MDR Text Key330071290
Report Number0001222315-2023-030511
Device Sequence Number1
Product Code OAT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Dentist
Type of Report Initial
Report Date 11/14/2023,12/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number109.496
Device Lot NumberCZM37
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/08/2023
Device Age37 MO
Event Location Other
Date Report to Manufacturer11/14/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age24 YR
Patient SexMale
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