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

Catalog Number	6035-06D
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), a dental implant analog was reported to be incorrectly manufactured.The orientation of the analog did not align with a 3d-printed model.
Additional Manufacturer Narrative
Follow-up submitted to report device not returned for evaluation.

• 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: 8324057
• Report Number: 3001617766-2019-00047
• Device Sequence Number: 11185304
• Product Code: NDP
• UDI-Device Identifier: 10841307123897
• UDI-Public: 10841307123897
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: DA
• PMA/510(K) Number: 872.3980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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: 6035-06D
• Device Lot Number: 119191
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1