MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY¿4 IMPLANT; DENTAL IMPLANT

Catalog Number 883210

Device Problem Device-Device Incompatibility (2919)

Patient Problem Failure of Implant (1924)

Event Date 04/30/2018

Event Type  malfunction  

Event Description

Per the complaint, after inserting the implant, the doctor was not able to remove the impression coping from the implant during surgery.

Manufacturer Narrative

Additional information available 07/16/2018.

• Brand Name: LEGACY¿4 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7656298
• MDR Text Key: 113013502
• Report Number: 3001617766-2018-00163
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307103196
• UDI-Public: 10841307103196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 06/03/2021
• Device Catalogue Number: 883210
• Device Lot Number: 79258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2016
• 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
• Patient Age: 80 YR