MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 2 IMPLANT; DENTAL IMPLANT

Model Number	825716
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Fibrosis (3167)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per (b)(4), the dental implant did not have primary stability.Patient experienced inflammation and fibrous tissue.

• Brand Name: LEGACY 2 IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 11592859
• Report Number: 3001617766-2021-01786
• Device Sequence Number: 4297261
• Product Code: DZE
• UDI-Device Identifier: 10841307101529
• UDI-Public: 10841307101529
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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 Expiration Date: 08/20/2024
• Device Model Number: 825716
• Device Catalogue Number: 825716
• Device Lot Number: 148068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 03/30/2021
• 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
• Patient Age: 84 YR
• Patient Weight: 68