MAUDE Adverse Event Report: NEODENT - JJGC S.A. TITAMAX SMART IMPLANT (4.1) 4.0X13 MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.163
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104)
Date of Event	02/15/2018
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 19 days after dental implant was installed in intraoral region 30#, its non-osseointegration was observed.The patient presented bone type ii.
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 19 days after dental implant was installed in intraoral region 30#, its non-osseointegration was observed.The patient presented bone type ii.

• Brand Name: TITAMAX SMART 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 Key: 7830138
• Report Number: 3008261720-2018-04294
• Device Sequence Number: 2434084
• Product Code: DZE
• UDI-Device Identifier: 07898237566771
• UDI-Public: 07898237566771
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K133510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• 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 Date: 03/01/2019
• Device Catalogue Number: 109.163
• Device Lot Number: 800118324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2018
• Device Age: 47 MO
• Event Location: Other
• Date Report to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention