MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX EX ACQUA IMPL TI 3.5X17; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.665
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104)
Date of Event	12/06/2017
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 3 months after the dental implant and abutment were placed in ada site 23, the implant had not yet integrated in type iii bone.Clinician noted bone loss, infection, pain and a fistula.A bone graft was performed with xenograft, 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 3 months after the dental implant and abutment were placed in ada site 23, the implant had not yet integrated in type iii bone.Clinician noted bone loss, infection, pain and a fistula.A bone graft was performed with xenograft, the product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.

• Brand Name: CM TITAMAX EX ACQUA IMPL TI 3.5X17
• 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: 7169519
• Report Number: 3008261720-2018-00077
• Device Sequence Number: 1773240
• Product Code: DZE
• UDI-Device Identifier: 07899878016779
• UDI-Public: 07899878016779
• 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: foreign
• Initial Reporter Occupation: Dental Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2018
• Report Date (Section F): 12/13/2017

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: 01/28/2019
• Device Catalogue Number: 140.665
• Device Lot Number: 94906
• Other Device ID Number: 07899878016779
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/09/2018
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 12/13/2017
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 04/09/2018
• 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, BONE GRAFT; ABUTMENT, BONE GRAFT; ABUTMENT, BONE GRAFT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR