MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM ZYGOMTIC IMPL TI 30; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.522
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	03/31/2017
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 that 5 months after the dental implant was placed, in ada site #14 of the patient's mouth loss of osseointegration was verified.Patient presented with type ii bone.Hygiene around the implant was fair.The product will be returned for investigation.No operative or post-operative complications were reported for the patient.
Event or Problem Description
The clinician reported that 5 months after the dental implant was placed, in ada site #14 of the patient's mouth loss of osseointegration was verified.Patient presented with type ii bone.Hygiene around the implant was fair.The product will be returned for investigation.No operative or post-operative complications were reported for the patient.

• Brand Name: CM ZYGOMTIC IMPL TI 30
• 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: 7030147
• Report Number: 3008261720-2017-05295
• Device Sequence Number: 19151144
• Product Code: DZE
• UDI-Device Identifier: 07898237567761
• UDI-Public: 07898237567761
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K101207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017
• Report Date (Section F): 04/20/2017

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: Dentist
• Device Expiration Date: 07/07/2019
• Device Catalogue Number: 109.522
• Device Lot Number: 800194166
• Other Device ID Number: 07898237567761
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/22/2017
• Event Location: Other
• Date Report to Manufacturer: 04/20/2017
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 04/20/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 12/22/2017
• 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: 74 YR