MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM DRIVE ACQUA IMPLANT 5.0X8; ENDOSSEOUS DENTAL IMPLANT

Catalog Number 140.690

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The clinician reported that on the day the implant was placed in the mouth, primary stability was not achieved.The implant was covered in bone.Clinician reports user error.Another implant was not placed in the same site and the site was not grafted.The product will be forwarded to the manufacturer for investigation.There were no reported patient complications.

Manufacturer Narrative

(b)(4).

Event Description

The clinician reported that on the day the implant was placed in the mouth, primary stability was not achieved.The implant was covered in bone.Clinician reports user error.Another implant was not placed in the same site and the site was not grafted.The product will be forwarded to the manufacturer for investigation.There were no reported patient complications.(b)(4).

• Brand Name: CM DRIVE ACQUA IMPLANT 5.0X8
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NEODENT - JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• Manufacturer (Section G): NEODENT - JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; 9787472509
• MDR Report Key: 7874876
• MDR Text Key: 120237401
• Report Number: 3008261720-2018-04566
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07899878016915
• UDI-Public: 07899878016915
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 08/06/2018,09/13/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2019
• Device Catalogue Number: 140.690
• Device Lot Number: 800310244I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2018
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 08/06/2018
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR