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

Catalog Number	109687
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.In telephone contact, the dentist informed that he did not have information about lot number of the product.Considering the surgical methodology, the dentist reported that the implant was immediately installed in an alveolus with signs of injury/ infection.It was also seen that the dentist has used more drills than recommended to perform the implant installation.
Event or Problem Description
(b)(4) ¿ the dentist reported that 15 days after dental implant was installed in intraoral region #6, its non-osseointegration was observed.In addition, 60ncm of primary stability was achieved, the patient presented bone type iii and the procedures of immediate implant and immediate load were performed.

• Brand Name: CM DRIVE IMPLANT 5.0X16
• 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: 7346871
• Report Number: 3008261720-2018-01273
• Device Sequence Number: 19411241
• Product Code: DZE
• UDI-Device Identifier: 07898237569253
• UDI-Public: 07898237569253
• 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: 2017
• Device Explanted Year: 2017
• 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): 02/27/2018

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 Catalogue Number: 109687
• Other Device ID Number: 07898237569253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/16/2018
• Event Location: Other
• Date Report to Manufacturer: 02/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• 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: 47 YR