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

Catalog Number 6043-06D

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2019

Event Type  malfunction  

Event 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
• Type of Device: DENTAL IMPLANT ANALOG
• 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: 8506769
• MDR Text Key: 141765903
• Report Number: 3001617766-2019-00159
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307123903
• UDI-Public: 10841307123903
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 872.3980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/08/2023
• Device Catalogue Number: 6043-06D
• Device Lot Number: 121455
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2018
• 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