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

Catalog Number	140.638
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pain (1994); Tissue Damage (2104)
Date of Event	08/30/2018
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
The clinician reported that over 1.5 yrs.After the dental implant and bridge were placed in ada site 4 in the mouth, the implant lost osseo- integration in type iv bone.Clinician noted patient's bone resorption, pain, mobility, bleeding, inflammation and abscess.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.
Event or Problem Description
The clinician reported that over 1.5 yrs.After the dental implant and bridge were placed in ada site 4 in the mouth, the implant lost osseo- integration in type iv bone.Clinician noted patient's bone resorption, pain, mobility, bleeding, inflammation and abscess.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 IMPLANT 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: 7944924
• Report Number: 3008261720-2018-04947
• Device Sequence Number: 941632
• Product Code: DZE
• UDI-Device Identifier: 07899878016571
• UDI-Public: 07899878016571
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/08/2018
• Report Date (Section F): 09/27/2018

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: 07/28/2018
• Device Catalogue Number: 140.638
• Device Lot Number: 63606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/17/2018
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 11/23/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR