MAUDE Adverse Event Report: DENTIUM USA SUPERLING; DENTAL IMPLANT

Model Number	FX6010SWC
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The dental implant fx6010swc was removed on (b)(6) 2017 due to failure to osseointegrate 1 month and 13 days after implantation.The patient has no significant medical history.The patient required another surgical intervention.

• Brand Name: SUPERLING
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): DENTIUM USA; 6761 katella ave; cypress CA 90630
• MDR Report Key: 7390883
• Report Number: 3005503242-2018-00066
• Device Sequence Number: 238195
• Product Code: DZE
• UDI-Device Identifier: D755FX6010SWC0
• UDI-Public: D755FX6010SWC0
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/02/2018

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: 03/16/2024
• Device Model Number: FX6010SWC
• Device Catalogue Number: FX6010SWC
• Device Lot Number: B23RA996S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 04/02/2018
• 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: 57 YR