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

Catalog Number	834706
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight was not provided.When the requested information becomes available, a supplementary report will be submitted.Pma/510(k) - not applicable.
Event or Problem Description
Per complaint(b)(4),during clinical procedure, patient experienced loss or failure of implant to integrate.

• Brand Name: LEGACY 2 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: 10586614
• Report Number: 3001617766-2020-06740
• Device Sequence Number: 14117350
• Product Code: DZE
• UDI-Device Identifier: 10841307101758
• UDI-Public: 10841307101758
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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 Expiration Date: 07/19/2023
• Device Catalogue Number: 834706
• Device Lot Number: 119229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/25/2020
• 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: 66 YR