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

Catalog Number	9048-40
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8834929
• Report Number: 3001617766-2019-00324
• Device Sequence Number: 2390379
• Product Code: NHA
• UDI-Device Identifier: 10841307115984
• UDI-Public: 10841307115984
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K081396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1