MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX EX ACQUA IMPL TI 4.0X13; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.638
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
Event or Problem Description
He clinician reported that less than 6 months after the dental implant and abutment were placed in ada site 10, the implant had not obtained integration in type i bone.Clinician reports pain and bruxism.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.Considering the surgical methodology, the dentist reported that the implant was immediately installed in an alveolus with signs of injury/ infection.Also, the dentist has selected an implant design which was not recommended for the patient's bone quality.
Event or Problem Description
He clinician reported that less than 6 months after the dental implant and abutment were placed in ada site 10, the implant had not obtained integration in type i bone.Clinician reports pain and bruxism.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 4.0X13
• 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: 7606509
• Report Number: 3008261720-2018-02686
• Device Sequence Number: 16618856
• Product Code: DZE
• UDI-Device Identifier: 07899878016571
• UDI-Public: 07899878016571
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018
• Report Date (Section F): 05/22/2018

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: 08/22/2018
• Device Catalogue Number: 140.638
• Device Lot Number: 63611
• Other Device ID Number: 07899878016571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• 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: 05/22/2018
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 06/15/2018
• 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 PLACEMENT; ABUTMENT PLACEMENT; ABUTMENT PLACEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR