MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISH GOLD ENGAGING ABUTMENT

Catalog Number 9048-40

Device Problem Inaccurate Information (4051)

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2019

Event Type  malfunction  

Event Description

Per complaint (b)(4), it was reported than a dental abutment vial had the incorrect top-label.No patient involvement was reported.

• Brand Name: SWISH GOLD ENGAGING ABUTMENT
• Type of Device: ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: monica roche ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 8834929
• MDR Text Key: 153954441
• Report Number: 3001617766-2019-00324
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307115984
• UDI-Public: 10841307115984
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K081396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 9048-40
• Device Lot Number: 71582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1