MAUDE Adverse Event Report: NEODENT - JJGC S.A. FACILITY IMPLANT 14.0 MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.739
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	01/01/2018
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.It is suggested that the main factor of the fracture was occlusal overload.The excess occlusal forces on the component will not be dissipated correctly along the long axis of the implant, favoring the fracture of the component.
Event or Problem Description
(b)(4).The dentist reported that dental implant had to be removed due to the fracture of the component.Moreover, the patient presented bone type i and bone graft was executed.
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.It is suggested that the main factor of the fracture was occlusal overload.The excess occlusal forces on the component will not be dissipated correctly along the long axis of the implant, favoring the fracture of the component.
Event or Problem Description
(b)(4) ¿ the dentist reported that dental implant had to be removed due to the fracture of the component.Moreover, the patient presented bone type i and bone graft was executed.

• Brand Name: FACILITY IMPLANT 14.0 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: 7830092
• Report Number: 3008261720-2018-04296
• Device Sequence Number: 13750113
• Product Code: DZE
• UDI-Device Identifier: 07898237569529
• UDI-Public: 07898237569529
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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 Catalogue Number: 109.739
• 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
• 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