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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JJGC S.A. CM DRIVE IMPL TI 5.0X13; ENDOSSEOUS DENTAL IMPLANT
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JJGC S.A. CM DRIVE IMPL TI 5.0X13; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 109.686
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Pain (1994); Fibrosis (3167)
Date of Event 04/19/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 14.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bone type iii, fair oral hygiene and inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.
 
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Brand Name
CM DRIVE IMPL TI 5.0X13
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 Key11004810
Report Number0001222315-2020-16410
Device Sequence Number4563532
Product Code DZE
UDI-Device Identifier07898237569246
UDI-Public07898237569246
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K123022
Number of Events Summarized1
Summary Report (Y/N)Y
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 12/14/2020
Report Date (Section F) 11/19/2020
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 Date06/12/2020
Device Model Number109.686
Device Catalogue Number109.686
Device Lot Number800193407I
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/14/2020
Device Age58 MO
Event Location Other
Date Report to Manufacturer11/19/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/19/2020
Initial Report FDA Received Date12/14/2020
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;
Patient Age53 YR
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