MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC OFF-AXIS DRIVER ACCESS PLUG; DENTAL IMPLANT

Catalog Number	DAP
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), the udi number on the product label was incorrect.This is an internal complaint, there was no patient involvement.

• Brand Name: OFF-AXIS DRIVER ACCESS PLUG
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 9800302
• Report Number: 3001617766-2020-01905
• Device Sequence Number: 609758
• Product Code: NDP
• UDI-Device Identifier: 10841307122968
• UDI-Public: 10841307122968
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

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: 11/21/2021
• Device Catalogue Number: DAP
• Device Lot Number: 86493
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention