MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY CUSTOM TI ABUTMENT ASSY 4.3MMD; DENTAL IMPLANT

Model Number	8045-31-XX
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor claims that the abutment is too wide and he was unable to seat it comfortably on the patient due to it pinching the papilla.He is requesting that we remake the abutment.Procedure required second surgery to complete.This is a reportable serious injury.

• Brand Name: LEGACY CUSTOM TI ABUTMENT ASSY 4.3MMD
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7441857
• Report Number: 3001617766-2018-00069
• Device Sequence Number: 1094590
• Product Code: DZE
• UDI-Device Identifier: 10841307116851
• UDI-Public: 10841307116851
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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?: Yes
• Operator of Device: Dentist
• Device Model Number: 8045-31-XX
• Device Catalogue Number: 8045-31-XX
• Device Lot Number: 110240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention