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

Model Number	8045-61
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced loss or failure of implant to integrate.
Additional Manufacturer Narrative
The original mdr 3500a for this event was submitted in error.The abutment was returned with a failed implant.There is no report of a product malfunction or adverse patient impact for this event.(b)(6) 2021.

• Brand Name: LEGACY OVERDENTURE ABUTMENT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9646147
• Report Number: 3001617766-2020-01118
• Device Sequence Number: 18911922
• Product Code: NHA
• UDI-Device Identifier: 10841307111511
• UDI-Public: 10841307111511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 12/07/2022
• Device Model Number: 8045-61
• Device Catalogue Number: 8045-61
• Device Lot Number: 105062
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/24/2021
• 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