MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX EX ACQUA IMPL TI 3.5X15; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.664
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Damage (2104)
Date of Event	04/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.
Event or Problem Description
The clinician reported that nearly 6 months after the dental implant and full lower restoration were placed (ada site 29 in the mouth), the implant failed due to a biomechanical overload.Clinician reports peri- implantitis, bone loss and inflammation.The product will be forwarded to the manufacturer for investigation.There were no reported post- operative complications.
Additional Manufacturer Narrative
Exemption number: e2015015.
Event or Problem Description
The clinician reported that nearly 6 months after the dental implant and full lower restoration were placed ((b)(6) site 29 in the mouth), the implant failed due to a biomechanical overload.Clinician reports peri- implantitis, bone loss and inflammation.The product will be forwarded to the manufacturer for investigation.There were no reported post- operative complications.(b)(4).

• Brand Name: CM TITAMAX EX ACQUA IMPL TI 3.5X15
• 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: 7527184
• Report Number: 3008261720-2018-02293
• Device Sequence Number: 16610050
• Product Code: DZE
• UDI-Device Identifier: 07899878016762
• UDI-Public: 07899878016762
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018
• Report Date (Section F): 05/01/2018

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: Health Professional
• Device Expiration Date: 01/21/2019
• Device Catalogue Number: 140.664
• Device Lot Number: 91100
• Other Device ID Number: 07899878016762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/29/2018
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 05/01/2018
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 08/29/2018
• 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: ABUTMENT REMOVAL; ABUTMENT REMOVAL; ABUTMENT REMOVAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR