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

Catalog Number	109739
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	01/19/2018
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
(b)(4).The dentist reported that 2 years and 11 months after dental implant was installed in intraoral region #7, its non- osseointegration was observed.In addition, 32ncm of primary stability was achieved, the patient presented bone type iii and the procedures of immediate load and immediate implant were performed.The dentist also reported that occlusal overload happened.

• Brand Name: FACILITY IMPLANT 14.0
• 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: 7346855
• Report Number: 3008261720-2018-01247
• Device Sequence Number: 2312600
• Product Code: DZE
• UDI-Device Identifier: 07898237569529
• UDI-Public: 07898237569529
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/16/2018
• Report Date (Section F): 02/23/2018

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: Dentist
• Device Expiration Date: 02/22/2019
• Device Catalogue Number: 109739
• Device Lot Number: 800088539
• Other Device ID Number: 07898237569529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/16/2018
• Device Age: 47 MO
• Event Location: Other
• Date Report to Manufacturer: 02/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/16/2018
• 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
• Patient Age: 19 YR