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

Catalog Number	140.640
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Swelling (2091)
Date of Event	11/21/2017
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
The clinician reported that nearly 2 months after the dental implant in ada site 10 was placed, the implant had not yet integrated in type iii bone.Clinician reports an infection, pain, fistula and swelling.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.
Event or Problem Description
The clinician reported that nearly 2 months after the dental implant in ada site 10 was placed, the implant had not yet integrated in type iii bone.Clinician reports an infection, pain, fistula and swelling.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 4.0X17
• 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: 7157374
• Report Number: 3008261720-2018-00004
• Device Sequence Number: 18859875
• Product Code: DZE
• UDI-Device Identifier: 07899878016595
• UDI-Public: 07899878016595
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dental Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2018
• Report Date (Section F): 12/06/2017

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: Dentist
• Device Expiration Date: 01/26/2019
• Device Catalogue Number: 140.640
• Device Lot Number: 90211
• Other Device ID Number: 07899878016595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2018
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 12/06/2017
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 04/25/2018
• 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; ABUTMENT; ABUTMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR