MAUDE Adverse Event Report: NEODENT - JJGC S.A. EXTERNAL HEX ZYGOMATIC IMPLANT 35.0; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.450
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104)
Date of Event	01/02/2019
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 7 months after the dental implant and abutment were placed in ada site 4 in the mouth, the implant did not achieve osseointegration in type ii bone.Clinician noted the patient's pain.The implant was torqued to 35 ncm.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 investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form, visual conference of the product returned by the dentist and the evaluation of relevant production records.
Event or Problem Description
The clinician reported that 7 months after the dental implant and abutment were placed in ada site 4 in the mouth, the implant did not achieve osseointegration in type ii bone.Clinician noted the patient's pain.The implant was torqued to 35 ncm.The product will be forwarded to the manufacturer for investigation.There were no reported post- operative complications.(b)(4).

• Brand Name: EXTERNAL HEX ZYGOMATIC IMPLANT 35.0
• 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: 8302481
• Report Number: 3008261720-2019-00556
• Device Sequence Number: 10801683
• Product Code: DZE
• UDI-Device Identifier: 07898237567280
• UDI-Public: 07898237567280
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2019
• Report Date (Section F): 01/25/2019

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: 01/16/2021
• Device Catalogue Number: 109.450
• Device Lot Number: 67225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/07/2019
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 05/07/2019
• 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: ABUTMENT REMOVAL; ABUTMENT REMOVAL; ABUTMENT REMOVAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR