MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM ALVIM ACQUA IMPL TI 5.0X13; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.655
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	03/22/2017
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 11 days after the dental implant was placed in the patient's mouth non-osseointegration was observed.The device will be forwarded to the manufacturer for investigation.There were no reported patient injuries or complications.
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
Event or Problem Description
(b)(4) - the clinician reported that 11 days after the dental implant was placed in the patient's mouth non-osseointegration was observed.The device will be forwarded to the manufacturer for investigation.There were no reported patient injuries or complications.
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
Event or Problem Description
(b)(4)- the clinician reported that 11 days after the dental implant was placed in the patient's mouth non-osseointegration was observed.There were no reported patient injuries or complications.

• Brand Name: CM ALVIM ACQUA IMPL TI 5.0X13
• 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: 7030139
• Report Number: 3008261720-2017-05286
• Device Sequence Number: 16466929
• Product Code: DZE
• UDI-Device Identifier: 07899878016670
• UDI-Public: 07899878016670
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101207
• 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: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2018
• Report Date (Section F): 04/10/2017

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: 06/26/2017
• Device Catalogue Number: 140.655
• Device Lot Number: 60745
• Other Device ID Number: 07899878016670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/19/2018
• Event Location: Other
• Date Report to Manufacturer: 04/10/2017
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: 04/10/2017; 11/21/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 01/17/2018; 01/18/2018
• 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: 41 YR