MAUDE Adverse Event Report: DENTIUM USA SUPERLINE; DENTAL IMPLANT

Model Number	FX4512SWC
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)
Date of Event	09/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reported the implant was removed due to osseointegration failure less than a month after placement surgery.Oral hygiene at the site of the implant was good.During the surgery, no significant findings were observed.

• Brand Name: SUPERLINE
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): DENTIUM USA; 6761 katella ave; cypress CA 90630
• MDR Report Key: 10587731
• Report Number: 3005503242-2020-00157
• Device Sequence Number: 14158812
• Product Code: DZE
• UDI-Device Identifier: D755FX4512SWC0
• UDI-Public: D755FX4512SWC0
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: No Information
• Device Model Number: FX4512SWC
• Device Catalogue Number: FX4512SWC
• Device Lot Number: F06OB381S
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 09/25/2020
• 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: 56 YR