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

Model Number 8735-05

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 10/11/2017

Event Type  malfunction  

Event 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
• Type of Device: TRANSFER
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: lia meshwork ; 3050 east hillcrest drive; thousand oaks, CA 91362
• MDR Report Key: 7484221
• MDR Text Key: 107447385
• Report Number: 3001617766-2018-00087
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307121466
• UDI-Public: 10841307121466
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1