MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM DRIVE ACQUA IMPL TI 5.0X13; ENDOSSEOUS DENTAL IMPLANT

Model Number	N/A
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reported that 1.5 months after the dental implant was placed in ada site 13 in the patient's mouth, the implant did not achieve osseointegration in type ii bone.The clinician reported an infection, pain, implant mobility and bleeding in this patient with fair oral hygiene.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.

• Brand Name: CM DRIVE ACQUA IMPL TI 5.0X13
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NEODENT - JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba, 81270 -200; BR 81270-200
• MDR Report Key: 9084325
• Report Number: 1222315-2019-08565
• Device Sequence Number: 11427111
• Product Code: DZE
• UDI-Device Identifier: 07899878016878
• UDI-Public: 7899878016878
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/16/2019
• Report Date (Section F): 09/13/2019

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: 08/16/2019
• Device Model Number: N/A
• Device Catalogue Number: 140.686
• Device Lot Number: 800314545I
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2019
• Device Age: 22 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR