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

Model Number	855206
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot information unknown and if it becomes available a follow-up report will be submitted.
Event or Problem Description
Per (b)(4), during clinical procedure, patient experienced failure of implant to integrate.

• 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
• MDR Report Key: 9882171
• Report Number: 3001617766-2020-02967
• Device Sequence Number: 2794679
• Product Code: DZE
• UDI-Device Identifier: 10841307102212
• UDI-Public: 10841307102212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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 Model Number: 855206
• Device Catalogue Number: 855206
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/26/2020
• 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: 62 YR