MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM ZYGOMATIC IMPLANT 45.0; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.525
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Tissue Damage (2104)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
Event or Problem Description
The clinician reported that 10 months after the dental implant and provisional abutment were placed in ada site 3 in the mouth, the implant failed to achieve osseointegration.Clinician noted patient's peri- implantitis, pain, mobility and bruxism.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.
Event or Problem Description
The clinician reported that 10 months after the dental implant and provisional abutment were placed in ada site 3 in the mouth, the implant failed to achieve osseointegration.Clinician noted patient's peri- implantitis, pain, mobility and bruxism.The product will be forwarded to the manufacturer for investigation.There were no reported post- operative complications.(b)(4).

• Brand Name: CM ZYGOMATIC IMPLANT 45.0
• 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: 7971386
• Report Number: 3008261720-2018-05040
• Device Sequence Number: 1739030
• Product Code: DZE
• UDI-Device Identifier: 07898237567792
• UDI-Public: 07898237567792
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018
• Report Date (Section F): 10/08/2018

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 Expiration Date: 03/14/2019
• Device Catalogue Number: 109.525
• Device Lot Number: 800182333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/14/2018
• Device Age: 2 MO
• Event Location: Other
• Date Report to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROVISIONAL ABUTMENT; PROVISIONAL ABUTMENT; PROVISIONAL ABUTMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR