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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Tissue Damage (2104)
Date of Event 05/03/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 had to remove the dental implant during its installation surgery due to patient¿s conditions.Moreover, the patient presented bone type ii.
 
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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 Key8953832
Report Number3008261720-2019-04421
Device Sequence Number2399854
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 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) 09/02/2019
Report Date (Section F) 08/06/2019
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 Date01/05/2023
Device Catalogue Number109.297
Device Lot Number132306
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/02/2019
Device Age4 MO
Event Location Other
Date Report to Manufacturer08/06/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/06/2019
Initial Report FDA Received Date09/02/2019
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;
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