MAUDE Adverse Event Report: DENTIUM USA SUPERLINE; DENTAL IMPLANT

Model Number	FX5012SWC
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
[(b)(4).Jpg].
Event or Problem Description
The dental implant fx5012swc was removed on (b)(6) 2018 due to failure to osseointegrate 3 months and 26 days after implantation.The patient is a tobacco user but has no other significant medical history.The patient has recovered without complications.
Event or Problem Description
The dental implant fx5012swc was removed on (b)(6) 2018 due to failure to osseointegrate 3 months and 26 days after implantation.The patient is a tobacco user but has no other significant medical history.The patient has recovered without complications.
Additional Manufacturer Narrative
See attached summary memo of evaluation.

• Brand Name: SUPERLINE
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): DENTIUM USA; 6761 katella ave; cypress CA 90630
• MDR Report Key: 7539069
• Report Number: 3005503242-2018-00085
• Device Sequence Number: 1871765
• Product Code: DZE
• UDI-Device Identifier: D755FX5012SWC0
• UDI-Public: D755FX5012SWC0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

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: Dentist
• Device Expiration Date: 04/25/2025
• Device Model Number: FX5012SWC
• Device Catalogue Number: FX5012SWC
• Device Lot Number: D12QB099S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 08/07/2018
• 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: 85 YR