MAUDE Adverse Event Report: DENTIUMUSA IMPLANTIUM; DENTAL IMPLANT

Model Number	FX4810MLC
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The dental implant fx4810mlc was removed on (b)(6) 2019 due to failure to osseointegrate 3 months after implantation.The patient has no significant medical history.The patient has recovered without complications.

• Brand Name: IMPLANTIUM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): DENTIUMUSA; 6761 katella ave; cypress, ca
• MDR Report Key: 9988429
• Report Number: 3005503242-2020-00047
• Device Sequence Number: 11687379
• Product Code: DZE
• UDI-Device Identifier: D755FX4810MLC0
• UDI-Public: D755FX4810MLC0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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: Health Professional
• Device Model Number: FX4810MLC
• Device Catalogue Number: FX4810MLC
• Device Lot Number: B07OB383S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 04/22/2020
• 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: 68 YR