MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT IMPLANT ANALOG; DENTAL IMPLANT ANALOG

Catalog Number	6043-06D
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), it was discovered that there was an issue of orientation on a 3d printed model of a dental implant analog.The lobes and flats of the part were not aligned correctly.

• Brand Name: REPLANT IMPLANT ANALOG
• Common Device Name: DENTAL IMPLANT ANALOG
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8506769
• Report Number: 3001617766-2019-00159
• Device Sequence Number: 1147804
• Product Code: NDP
• UDI-Device Identifier: 10841307123903
• UDI-Public: 10841307123903
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 872.3980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/08/2023
• Device Catalogue Number: 6043-06D
• Device Lot Number: 121455
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1