MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY CLOSED TRAY IMPLANT TRANSFER 3.5MMD PLATFORM

Model Number	8735-05
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
While putting inventory away in preparation for a patient, complainant noted a mislabeling issue.It was noticed that the top lid sticker was wrong ((b)(4), lot 90212) and the vial label was correct - (b)(4), 90212.This report is associated with health hazard evaluation (b)(4) for complaint number (b)(4).

• Brand Name: LEGACY CLOSED TRAY IMPLANT TRANSFER 3.5MMD PLATFORM
• Common Device Name: TRANSFER
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7484221
• Report Number: 3001617766-2018-00087
• Device Sequence Number: 194619
• Product Code: NDP
• UDI-Device Identifier: 10841307121466
• UDI-Public: 10841307121466
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Dentist
• Device Model Number: 8735-05
• Device Catalogue Number: 8735-05
• Device Lot Number: 90212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1