MAUDE Adverse Event Report: NEODENT - JJGC S.A. TI TITAMAX EX IMPL TI (4.1)4.0X17; ENDOSSEOUS DENTAL IMPLANT

Model Number	N/A
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reported that 3 months after the dental implant was placed in ada site 15 in the patient's mouth, the implant did not achieve osseointegration in type ii bone.The site was grafted.The clinician reported the patient's peri-implantitis, pain, swelling and inadequate healing.The implant was torqued to 20 ncm.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.

• Brand Name: TI TITAMAX EX IMPL TI (4.1)4.0X17
• 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: 9226394
• Report Number: 1222315-2019-11014
• Device Sequence Number: 13984742
• Product Code: DZE
• UDI-Device Identifier: 07898237568447
• UDI-Public: 7898237568447
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/23/2019
• Report Date (Section F): 10/10/2019

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: 09/04/2019
• Device Model Number: N/A
• Device Catalogue Number: 109.592
• Device Lot Number: 800150285
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/09/2019
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BONE GRAFT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR