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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. TI TITAMAX IMPLANT (5.0)4.5X9 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TI TITAMAX IMPLANT (5.0)4.5X9 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.327
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Pain (1994); Tissue Damage (2104)
Date of Event 03/25/2018
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 3 days after the dental implant was installed in patient¿s mouth, its non- osseointegration was observed.Moreover, the patient presented bone type i, biomechanical overload and bone overheating has occurred.
 
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Brand Name
TI TITAMAX IMPLANT (5.0)4.5X9 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 Key8396965
Report Number3008261720-2019-00963
Device Sequence Number11510472
Product Code DZE
UDI-Device Identifier07898237567129
UDI-Public07898237567129
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K101207
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) 03/06/2019
Report Date (Section F) 02/11/2019
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 Date04/28/2022
Device Catalogue Number109.327
Device Lot Number800300987
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/06/2019
Device Age11 MO
Event Location Other
Date Report to Manufacturer02/11/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/11/2019
Initial Report FDA Received Date03/06/2019
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 Age34 YR
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