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

Model Number	140.590
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Three attempts of contact with the dentist were performed, in order to obtain the missing information about lot number, but without success.The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form and visual conference of the product returned by the dentist.Considering the surgical methodology, it was seen that the dentist has selected an implant design which is not recommended for the patient's bone quality.Considering the surgical methodology, it was seen that the dentist has used sequence of drills different than the one recommended for the implant installation.
Event or Problem Description
(b)(4) ¿ the dentist reported that almost 03 months was installed in intraoral region 05#, its non-osseointegration was observed.Moreover, achieved and the patient presented bone type ii.

• 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 Key: 9889874
• Report Number: 3008261720-2020-01611
• Device Sequence Number: 2208986
• Product Code: DZE
• UDI-Device Identifier: 07899878016427
• UDI-Public: 07899878016427
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K133592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/27/2020
• Report Date (Section F): 02/28/2020

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 Model Number: 140.590
• Device Catalogue Number: 140.590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/27/2020
• Event Location: Other
• Date Report to Manufacturer: 02/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/27/2020
• 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
• Patient Age: 68 YR