MAUDE Adverse Event Report: IMPLANT DIRECT LLC LEGACY¿3 IMPLANT; DENTAL IMPLANT

Model Number 855711

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Information (3190)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

Query on lot complaints of this lot revealed that no other complaints with this issue have been received.

Event Description

From doctor - "implant fell off mount in patients mouth.Defective fit of mount resulted in implant falling into patients mouth.".

• Brand Name: LEGACY¿3 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• Manufacturer Contact: evan garner ; 3050 e hillcrest dr.; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7047192
• MDR Text Key: 93183441
• Report Number: 3001617766-2017-00014
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307102304
• UDI-Public: 10841307102304
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 06/24/2021
• Device Model Number: 855711
• Device Catalogue Number: 855711
• Device Lot Number: 80582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1