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

Catalog Number	6035-30CB
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation not possible due to the product being discarded.
Event or Problem Description
Per complaint (b)(4), a 6035-30cb dental abutment base did not fit the respective analog.The label was correct, but the incorrect part was received.

• Brand Name: REPLANT ZIRCONIA ABUTMENT BASE
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8251092
• Report Number: 3001617766-2019-00024
• Device Sequence Number: 1439919
• Product Code: NHA
• UDI-Device Identifier: 10841307114024
• UDI-Public: 10841307114024
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143011
• 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): 01/15/2019

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 Expiration Date: 03/12/2023
• Device Catalogue Number: 6035-30CB
• Device Lot Number: 111114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1