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

Catalog Number 6035-06D

Device Problem Component Misassembled (4004)

Patient Problem No Patient Involvement (2645)

Event Date 01/10/2019

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Follow-up submitted to report device not returned for evaluation.

• 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
• MDR Report Key: 8324057
• MDR Text Key: 136153024
• Report Number: 3001617766-2019-00047
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307123897
• UDI-Public: 10841307123897
• Combination Product (y/n): N
• PMA/PMN Number: 872.3980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 6035-06D
• Device Lot Number: 119191
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 05/07/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1