MAUDE Adverse Event Report: NEODENT - JJGC S.A. TITAMAX SMART EX IMPLANT (4.1) 3.75X11 MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.775
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The information provided in this report was based on information given by the dentist in neodent¿s products warranty form that was recorded in the system and is used by both the manufacturer and the subsidiary.The original complaint and the product were received by the subsidiary and did not arrive in the manufacturer yet.When this happens, a new evaluation of the complaint will be carried out and, if necessary, a new follow-up report will be send.
Event or Problem Description
(b)(4)- the dentist reported that 3 years and 10 months after the dental implant was installed in patient¿s mouth, its loss of osseointegration was observed.Moreover, 25n.Cm of primary stability was achieved and the patient presented bone type ii.
Additional Manufacturer Narrative
The complaint was received by the manufacturer and, after analysis, it was seen that the item received is different from the item reported.However, the correct item does not have a 510k reference, so it will not be corrected in the mdr due to the system rules.The item reference was corrected only on the complaint file and the lot number was not considered.
Event or Problem Description
(b)(4).The dentist reported that 3 years and 10 months after the dental implant was installed in patient¿s mouth, its loss of osseointegration was observed.Moreover, 25n.Cm of primary stability was achieved and the patient presented bone type ii.

• Brand Name: TITAMAX SMART EX IMPLANT (4.1) 3.75X11 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: 8921875
• Report Number: 3008261720-2019-04202
• Device Sequence Number: 16676492
• Product Code: DZE
• UDI-Device Identifier: 07898237569833
• UDI-Public: 07898237569833
• 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: 2015
• 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): 08/22/2019
• Report Date (Section F): 07/29/2019

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 Expiration Date: 11/01/2018
• Device Model Number: 109.775
• Device Catalogue Number: 109.775
• Device Lot Number: 800108138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2020
• Device Age: 60 MO
• Event Location: Other
• Date Report to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 04/08/2020
• 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