MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM DRIVE IMPLANT 5.0X16 MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.687
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.Considering the surgical methodology, the dentist reported that the implant was immediately installed in an alveolus with signs of injury/ infection.
Event or Problem Description
(b)(4).The dentist reported that 8 days after the dental implant was installed in patient¿s mouth, its non-osseointegration was observed and occlusal overload has occurred.Moreover, 35n.Cm of primary stability was achieved, the patient presented insufficient bone quality/quantity (bone type iv), bone graft was placed, immediate implant was performed and immediate load procedure was done.

• Brand Name: CM DRIVE IMPLANT 5.0X16 MM
• 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: 8355055
• Report Number: 3008261720-2019-00747
• Device Sequence Number: 2127338
• Product Code: DZE
• UDI-Device Identifier: 07898237569253
• UDI-Public: 07898237569253
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K123022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/20/2019
• Report Date (Section F): 01/31/2019

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: 02/07/2020
• Device Catalogue Number: 109.687
• Device Lot Number: 800173817I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/20/2019
• Device Age: 43 MO
• Event Location: Other
• Date Report to Manufacturer: 01/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/20/2019
• 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: 66 YR