MAUDE Adverse Event Report: IMPLANT DIRECT MANUFACTURING LLC REPLANT® ZIRCONIA ABUTMENT BASE; DENTAL ABUTMENT

Catalog Number 6050-30CB

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2018

Event Type  malfunction  

Event Description

Per complaint (b)(4), the ceramic abutment base did not fit the 3.5mm platform as intended.Rather, it fit the 5.0mm platform.The complaint was discovered during laboratory procedure.There was no patient involvement.

• Brand Name: REPLANT® ZIRCONIA ABUTMENT BASE
• Type of Device: DENTAL ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT MANUFACTURING LLC; 3050 east hillcrest dr.; thousand oaks CA 91362
• Manufacturer Contact: monica roche ; 3050 east hillcrest dr.; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 8214612
• MDR Text Key: 132087537
• Report Number: 3001617766-2019-00003
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307114048
• UDI-Public: 10841307114048
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143011
• 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: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6050-30CB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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