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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) 5.0X13 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TI TITAMAX IMPLANT (5.0) 5.0X13 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.297
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Fistula (1862); Unspecified Infection (1930); Tissue Damage (2104)
Date of Event 11/18/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Considering the surgical methodology, it was seen that the dentist has used sequence of drills different than the one recommended for the implant installation.The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form, visual conference of the product returned by the dentist and the evaluation of relevant production records.
 
Event or Problem Description
(b)(4) ¿ the dentist reported that almost 4 months after the dental implant was installed in intraoral region 18#, its non-osseointegration was observed.Moreover, 45n.Cm of primary stability was achieved.
 
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Brand Name
TI TITAMAX IMPLANT (5.0) 5.0X13 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 Key9569204
Report Number3008261720-2020-00102
Device Sequence Number327937
Product Code DZE
UDI-Device Identifier07898237566979
UDI-Public07898237566979
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K101207
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/09/2020
Report Date (Section F) 12/12/2019
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 Date05/18/2023
Device Catalogue Number109.297
Device Lot Number800344675
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/09/2020
Device Age18 MO
Event Location Other
Date Report to Manufacturer12/12/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/12/2019
Initial Report FDA Received Date01/09/2020
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 Age60 YR
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