MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFATURING LLC LEGACY3 IMPLANT; DENTAL IMPLANT

Catalog Number 854208

Device Problem Device-Device Incompatibility (2919)

Patient Problem Failure of Implant (1924)

Event Date 04/17/2018

Event Type  malfunction  

Event Description

Per the complaint, during a delivery the customer couldn't separate the abutment from the implant because the internal hex to disconnect them was stripped after very little pressure.Another implant was placed immediately after removal.

• Brand Name: LEGACY3 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFATURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, CA 91362
• MDR Report Key: 7604259
• MDR Text Key: 111163308
• Report Number: 3001617766-2018-00145
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307102106
• UDI-Public: 10841307102106
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: 854208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR