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

Catalog Number	863713
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Sinus Perforation (2277); Osteopenia/ Osteoporosis (2651); Fibrosis (3167)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), during post operative check patient experienced loss or failure of implant to osseointegrate due to secondary infection.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated date of report for report submission date and relevant tests/laboratory data to report device evaluation results.Updated mfr site, report source for follow-up report submitter, date rec¿d by mfr for awareness date for report type and follow-up number.Updated if follow-up, what type for follow-up type, device evaluated by mfr for device evaluation status and method, result and conclusion codes.

• 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: 9081341
• Report Number: 3001617766-2019-03720
• Device Sequence Number: 11463728
• Product Code: DZE
• UDI-Device Identifier: 10841307102472
• UDI-Public: 10841307102472
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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 Expiration Date: 12/18/2022
• Device Catalogue Number: 863713
• Device Lot Number: 105283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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