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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. TI DRIVE ACQUA IMPLANT (4.3) 4.3X8 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TI DRIVE ACQUA IMPLANT (4.3) 4.3X8 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140.757
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Fistula (1862); Tissue Damage (2104)
Date of Event 09/24/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
 
Event or Problem Description
(b)(4) ¿ the dentist reported that 1 month and 7 days after the dental implant was installed in intraoral region 14#, its non- osseointegration was observed.Moreover, 20n.Cm of primary stability was achieved and the patient presented bone type iii.
 
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Brand Name
TI DRIVE ACQUA IMPLANT (4.3) 4.3X8 MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NEODENT - JJGC S.A.
av. juscelino kubitschek de
oliveira, 3291 cic
curitiba PR 81270 -200
BR  81270-200
MDR Report Key8407486
Report Number3008261720-2019-01031
Device Sequence Number269275
Product Code DZE
UDI-Device Identifier07899878017127
UDI-Public07899878017127
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K133592
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 03/11/2019
Report Date (Section F) 02/12/2019
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 Date10/11/2019
Device Catalogue Number140.757
Device Lot Number123422I
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/11/2019
Device Age11 MO
Event Location Other
Date Report to Manufacturer02/12/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2019
Initial Report FDA Received Date03/11/2019
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 Age50 YR
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