MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LOCATOR ABUTMENT LEGACY 3.0DIA X4.0MM; DENTAL ABUTMENT

Catalog Number	8530-94-I
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), a dentist's package for a 4mm collar locator abutment contained a 2mm collar.The dental procedure was not completed in the same visit.
Additional Manufacturer Narrative
Follow-up submitted to report.Device not returned for evaluation.Complaint cannot be confirmed.

• Brand Name: LOCATOR ABUTMENT LEGACY 3.0DIA X4.0MM
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8382892
• Report Number: 3001617766-2019-00076
• Device Sequence Number: 1062524
• Product Code: NHA
• UDI-Device Identifier: 10841307111283
• UDI-Public: 10841307111283
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: Health Professional
• Device Expiration Date: 03/27/2023
• Device Catalogue Number: 8530-94-I
• Device Lot Number: L0DEY
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1