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

Catalog Number	857006
Medical Device Problem Codes	Separation Failure (2547); Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), the coping was unable to be removed during dental implant placement.The coping stripped and the driver was unable to be placed.The implant was explanted on the same day.No adverse consequences were reported.

• Brand Name: LEGACY 3 IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8383838
• Report Number: 3001617766-2019-00077
• Device Sequence Number: 10867639
• Product Code: DZE
• UDI-Device Identifier: 10841307102335
• UDI-Public: 10841307102335
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K131097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/25/2022
• Device Catalogue Number: 857006
• Device Lot Number: 95189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1