MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY GOLD/PLASTIC ENGAGING ABUTMENT; DENTAL IMPLANT SUPRASTRUCTURE

Catalog Number	8530-40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As per complaint (b)(4), a dental implant broke/fractured after a clinical procedure and the implant was explanted.No adverse patient effect was recorded.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.

• Brand Name: LEGACY GOLD/PLASTIC ENGAGING ABUTMENT
• Common Device Name: DENTAL IMPLANT SUPRASTRUCTURE
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9088684
• Report Number: 3001617766-2019-02249
• Device Sequence Number: 2537653
• Product Code: NHA
• UDI-Device Identifier: 10841307111061
• UDI-Public: 10841307111061
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/25/2019

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 Catalogue Number: 8530-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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