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

Catalog Number	865708
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Failure of Implant (1924); Sinus Perforation (2277)
Date of Event	05/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), a patient's dental implant was placed and bone was grafted into their sinus.Primary stability was achieved.Their dental implant fell out one week later.Possible sinus perforation was reported.No other 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: 8363079
• Report Number: 3001617766-2019-00063
• Device Sequence Number: 16670552
• Product Code: DZE
• UDI-Device Identifier: 10841307102687
• UDI-Public: 10841307102687
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• 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): 02/22/2019

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 Catalogue Number: 865708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/22/2019
• 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