MAUDE Adverse Event Report: NEODENT - JJGC S.A. FACILITY ACQUA IMPLANT 10; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.737
Medical Device Problem Codes	Failure to Osseointegrate (1863); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Tissue Damage (2104)
Date of Event	03/13/2017
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
The clinician reported 9 months after the dental implant was placed in ada site 11 in the mouth, the implant did not achieve osseointegration in type iii bone.Clinician noted the patient's pain and swelling.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.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 that 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
The clinician reported 9 months after the dental implant was placed in ada site 11 in the mouth, the implant did not achieve osseointegration in type iii bone.Clinician noted the patient's pain and swelling.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.
Additional Manufacturer Narrative
The complaint was received by manufacturer and, after analysis, new informations were obtained.A follow-up is being sent to correct these informations according to the evaluation made.
Event or Problem Description
The clinician reported 9 months after the dental implant was placed in ada site 11 in the mouth, the implant did not achieve osseointegration in type iii bone.Clinician noted the patient's pain and swelling.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.

• Brand Name: FACILITY ACQUA IMPLANT 10
• 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: 8434564
• Report Number: 3008261720-2019-01180
• Device Sequence Number: 1062934
• Product Code: DZE
• UDI-Device Identifier: 07899878017035
• UDI-Public: 07899878017035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2019
• Report Date (Section F): 02/28/2019

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: 06/28/2018
• Device Catalogue Number: 140.737
• Device Lot Number: 59240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/03/2019
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 06/21/2019; 08/27/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 07/04/2019; 09/03/2019
• 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: 73 YR