MAUDE Adverse Event Report: NEODENT - JJGC S.A. TI TITAMAX EX IMPLANT (4.1)3.75X17 MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.586
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Damage (2104)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Considering the surgical methodology, it was seen that the dentist has used sequence of drills different than the one recommended for the implant installation.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 1 year and 1 month after the dental implant was installed in patient¿s mouth, its loss of osseointegration was observed.Moreover, 60n.Cm of primary stability was achieved and the patient presented bone type ii.
Additional Manufacturer Narrative
After the evaluation was noticed that the item received is different from the item reported on guarantee form by the complainant.Therefore, the lot number was not considered.Considering the surgical methodology, it was seen that the dentist has used sequence of drills different than the one recommended for the implant installation.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.
Event or Problem Description
(b)(4) - the dentist reported that 1 year and 1 month after the dental implant was installed in patient¿s mouth, its loss of osseointegration was observed.Moreover, 60n.Cm of primary stability was achieved and the patient presented bone type ii.

• Brand Name: TI TITAMAX EX IMPLANT (4.1)3.75X17 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: 8953662
• Report Number: 3008261720-2019-04410
• Device Sequence Number: 13985622
• Product Code: DZE
• UDI-Device Identifier: 07898237568386
• UDI-Public: 07898237568386
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• 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 Catalogue Number: 109.586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/03/2020
• Event Location: Other
• Date Report to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 09/02/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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