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

Catalog Number	6050-30CB
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion code: cause traced to packaging.
Event or Problem Description
Per complaint (b)(4), the packaged product was suspected to consist of an incorrectly sized titanium base with the correctly sized screw.The abutment base was not used and there was no patient involvement.

• Brand Name: REPLANT ZIRCONIA ABUTMENT BASE
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e. hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 8174528
• Report Number: 3001617766-2018-00380
• Device Sequence Number: 19184132
• Product Code: NHA
• UDI-Device Identifier: 10841307114048
• UDI-Public: 10841307114048
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 12/18/2018

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: 6050-30CB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1