MAUDE Adverse Event Report: DENTIUMUSA SUPERLINE; DENTAL IMPLANT

Model Number	FX4014SWC
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The returned product is not a product of dentium usa.

• Brand Name: SUPERLINE
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): DENTIUMUSA; 6761 katella ave; cypress CA 90630
• MDR Report Key: 8107432
• Report Number: 3005503242-2018-00172
• Device Sequence Number: 2026537
• Product Code: DZE
• UDI-Device Identifier: D755FX4014SWC0
• UDI-Public: D755FX4014SWC0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/27/2018

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: 12/20/2025
• Device Model Number: FX4014SWC
• Device Catalogue Number: FX4014SWC
• Device Lot Number: L18QB039S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 11/27/2018
• 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: 58 YR