MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM DRIVE IMPLANT 4.3X13 MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.628
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	04/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.
Event or Problem Description
(b)(4) - the dentist reported that 5 months after the dental implant was installed in intraoral region #4 it was verified its non-osseointegration.No further information was provided.
Additional Manufacturer Narrative
Exemption number: e2015015.After the evaluation was noticed that the item received is different from the item reported on guarantee form by the complainant.Therefore, the lot number was not considered.
Event or Problem Description
(b)(4).The dentist reported that 5 months after the dental implant was installed in intraoral region #4 it was verified its non-osseointegration.No further information was provided.

• Brand Name: CM DRIVE IMPLANT 4.3X13 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: 7024189
• Report Number: 3008261720-2017-01132
• Device Sequence Number: 1901281
• Product Code: DZE
• UDI-Device Identifier: 07898237566665
• UDI-Public: 07898237566665
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2017
• Report Date (Section F): 01/04/2016

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 Catalogue Number: 109.628
• Other Device ID Number: 07898237566665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/26/2018
• Event Location: Other
• Date Report to Manufacturer: 01/04/2016
• Initial Date Received by Manufacturer: 01/04/2016
• Supplement Date Received by Manufacturer: 01/04/2016
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 09/26/2018
• 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: 31 YR