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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX IMPLANT 3.5X15 MM; ENDOSSEOUS DENTAL IMPLANT
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NEODENT - JJGC S.A. CM TITAMAX IMPLANT 3.5X15 MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 109.618
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 09/05/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.In telephone contact, the complainant informed that the information about lot number of the product was not available.Considering the surgical methodology, the dentist reported that the implant was immediately installed in an alveolus with signs of injury/ infection.It was also seen that the dentist has used more drills than recommended to perform the implant installation.
 
Event or Problem Description
(b)(4) ¿ the dentist reported that 20 days after the dental implant was installed in intraoral region 32#, its non-osseointegration was observed.In addition, 32ncm of primary stability was achieved, the patient presented bone type i, immediate load and immediate implant procedures were performed and biomechanical overload has occurred.
 
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Brand Name
CM TITAMAX IMPLANT 3.5X15 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 Key8201658
Report Number3008261720-2018-06089
Device Sequence Number13761632
Product Code DZE
UDI-Device Identifier07898237568706
UDI-Public07898237568706
Combination Product (Y/N)N
Initial Reporter CountryUY
PMA/510(K) Number
K101945
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) 12/28/2018
Report Date (Section F) 12/05/2018
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 Catalogue Number109.618
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/28/2018
Event Location Other
Date Report to Manufacturer12/05/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/05/2018
Initial Report FDA Received Date12/27/2018
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;
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