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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. TI TITAMAX EX ACQUA IMPLANT (4.1) 4.0X13 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. TI TITAMAX EX ACQUA IMPLANT (4.1) 4.0X13 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 140.590
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 06/19/2018
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
Rp.013926 ¿ the dentist reported that 4 months after dental implant was installed in intraoral region 12#, its non-osseointegration was observed.The patient presented poor bone quality/quantity (bone type iii) and immediate load procedure was performed.
 
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Brand Name
TI TITAMAX EX ACQUA IMPLANT (4.1) 4.0X13 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 Key7830152
Report Number3008261720-2018-04310
Device Sequence Number1517584
Product Code DZE
UDI-Device Identifier07899878016427
UDI-Public07899878016427
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) 08/29/2018
Report Date (Section F) 08/08/2018
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 Date08/26/2019
Device Catalogue Number140.590
Device Lot Number800316269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/29/2018
Device Age10 MO
Event Location Other
Date Report to Manufacturer08/08/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/08/2018
Initial Report FDA Received Date08/29/2018
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 Age47 YR
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